Prospective Clinical Study Research Articles

Individual lymph node position variation for rectal cancer patients treated with long course chemoradiotherapy

Background and purposeDelivery of high precision radiotherapy lymph node boosts requires detailed information on the interfraction positional variation of individual lymph nodes. In this study we characterized interfraction positional shifts of suspected malignant lymph nodes for rectal cancer patients receiving long course radiotherapy. Furthermore, we investigated parameters which could affect the magnitude of the position variation. Materials and MethodsFourteen patients from a prospective clinical imaging study with a total of 61 suspected malignant lymph nodes in the mesorectum, presacral, and lateral regions, were included. The primary gross tumor volume (GTVp) and all suspected malignant lymph nodes were delineated on six magnetic resonance imaging scans per patient. Positional variation was calculated as systematic and random errors, based on shifts of center-of-mass, and estimated relative to either bony structures or the GTVp using a hierarchical linear mixed model. ResultsDepending on location and direction, systematic and random variations (relative to bony structures) were within 0.6–2.8 mm and 0.6–2.9 mm, respectively. Systematic and random variations increased when evaluating position relative to GTVp (median increase of 0.6 mm and 0.5 mm, respectively). Correlations with scan time-point and relative bladder volume were found in some directions. ConclusionsUsing linear mixed modeling, we estimated systematic and random positional variation for suspected malignant lymph nodes in rectal cancer patients treated with long course radiotherapy. Statistically significant correlations of the magnitude of the lymph node shifts were found related to scan time-point and relative bladder volume.

Cross-cultural adaptation and psychometric validation of the French version of the Defense and Veterans Pain Rating Scale for acute and chronic pain: a prospective clinical study.

Pain assessment and proper evaluation of pain are prerequisites for treatment of acute and chronic pain. Until now, most evaluations have used only resting pain intensity and a unidimensional scale, although multidimensional pain assessment and especially assessment of functional pain impact on activities are recommended. The Defense and Veterans Pain Rating Scale (DVPRS) permits this multidimensional assessment, but no validated French translation exists. To validate the French translation of the multidimensional DVPRS, called the Functional Pain Scale (FPS), in multiple settings of acute and chronic pain. Prospective observational study. Two large hospitals in the French-speaking region of Switzerland. We recruited 232 patients from February 2022 to January 2023. Patients with acute or chronic pain in different settings received a paper questionnaire with both a numerical rating scale (NRS) and the FPS and a customized evaluation questionnaire. Correlation between the FPS and NRS, psychometric properties, and patient preferences were analyzed. Correlation between the FPS and NRS was high for the whole group of 232 patients, as well for all subgroups. The multi-item FPS scale showed excellent internal consistency. A large majority of patients, even those >75 years of age, preferred the FPS over the NRS and stated that the FPS was easy to use. The study confirms that the French translation of the DVPRS (the FPS) is a valid measurement instrument for acute and chronic pain evaluation in a wide range of patient groups and is easy for patients to use. ClinicalTrials.gov ID: NCT05307380.

Hyperspectral Imaging Detects Clitoral Vascular Issues in Gender-Affirming Surgery.

The aim of this study was to assess the efficacy of hyperspectral imaging (HSI) as an intraoperative perfusion imaging modality during gender affirmation surgery (GAS). The hypothesis posited that HSI could quantify perfusion to the clitoral complex, thereby enabling the prediction of either uneventful wound healing or the occurrence of necrosis. In this non-randomised prospective clinical study, we enrolled 30 patients who underwent GAS in the form of vaginoplasty with the preparation of a clitoral complex from 2020 to 2024 and compared patients' characteristics as well as HSI data regarding clitoris necrosis. Individuals demonstrating uneventful wound healing pertaining to the clitoral complex were designated as Group A. Patients with complete necrosis of the neo-clitoris were assigned to Group B. Patient characteristics were collected and subsequently a comparative analysis carried out. No significant difference in patient characteristics was observed between the two groups. Necrosis occurred when both StO2 and NIR PI parameters fell below 40%. For the simultaneous occurrence of StO2 and NIR PI of 40% or less, a sensitivity of 92% and specificity of 72% was calculated. Intraoperatively, the onset of necrosis in the clitoral complex can be reliably predicted with the assistance of HSI.

Influence of crown-lengthening surgery on teeth rehabilitated with ceramic single crowns: A 12-month prospective clinical study

ObjectiveTo compare the clinical periodontal parameters of teeth restored with a single ceramic crown, with and without crown lengthening procedure. MethodsThis prospective, longitudinal, controlled, and single-blinded clinical trial involved 22 patients with a total of forty-one teeth with ceramic crowns. The teeth were divided into two groups: test (n = 21), comprising teeth rehabilitated post crown-lengthening surgery, and control (n = 20), comprising teeth rehabilitated without crown-lengthening surgery. Plaque index (PI), gingival index (GI), probing depth (PD), bleeding on probing (BoP), and clinical attachment level (CAL) were compared between groups (surgically treated and non-surgically treated) and within each group for each type of site (treated -tt; adjacent – ad; and nonadjacent - nad). Additionally, gingival phenotype (GP), gingival recession (GR), and keratinized tissue width (KTW) were also assessed post- restoration. Statistical analyses used a significance level set at 5 %. ResultsPI, GI, and BoP were reduced, but no statistically significant differences were observed within each group or between groups for most follow-up periods. CAL of the TT sites was consistently higher in the test group, and PD was also higher in the test group (p < 0.05), except at T3. adPD, nadPD, adCAL, and nadCAL demonstrated no significant differences between groups and periods. A significant association was identified between GP and the occurrence of GR, with the thick-flat phenotype demonstrating less association with GR, regardless of whether crown lengthening was performed or not. ConclusionCrown-lengthening surgery in rehabilitated teeth does not significantly affect PI and GI after 12 months. Although crown-lengthening surgery affected PD and CAL in TT sites, it did not affect adjacent and non-adjacent sites. Clinical relevanceThese findings emphasize the importance of considering individual patient factors and the potential impact on periodontal tissues when planning crown-lengthening surgery. Clinicians must have a comprehensive understanding of the dynamics of the periodontal tissues involved in restorative treatments to optimize the procedure, increase success rates, and minimize potential complications.

Non-invasive intracranial pressure monitoring for high-grade gliomas patients treated with radiotherapy: results of the GMaPIC trial.

Patients with high-grade gliomas are at risk of developing increased intracranial hypertension (ICHT) in relation to the increase in volume of their tumor. ICP change cannot be measured by invasive method but can be estimated by using routine clinical signs, in combination with a standard imaging method, magnetic resonance imaging (MRI). A non-invasive monitoring of ICP could be of interest in high-grade glioma, in particular after radiotherapy treatment with as major side effect a cerebral oedema. This prospective clinical study aimed to compare the ICP changes (estimated by a non-invasive method based upon distortion product otoacoustic emissions (DPOAE) monitoring) with volume changes observed on MRI in patients with high-grade gliomas treated with radiotherapy. DPOAE measurements were performed one month after the end of radiotherapy and then every 3 months for one year. At each visit, the patient also underwent MRI as well as an evaluation of clinical signs. The variation in the estimate of intracranial pressure readout measured at each follow-up visit (in absolute value with respect to the baseline measurements) was significantly associated with the variation of T2/FLAIR volume (n=125; p<0.001) with a cut off value of change ICP readout of 40.2 degrees (e.i. an estimated change of 16 mm Hg). The GMaPIC trial confirm the hypothesis that the ICP change estimated by DPOAEs measurement using a non-invasive medical device is correlated with the change of the tumor or edema in high grade glioma after radiotherapy. The device could thus become an easy-to-use and non-invasive intracranial pressure monitoring tool for these patients. Clinicaltrials.gov, identifier (NCT02520492).

Post-treatment stability, survival time and periodontal health associated with vacuum-formed, bonded and rapid prototype retainers: A prospective clinical study

Background: New technologies have paved the way for newer fabrication techniques, such as rapid prototyping, which has gained popularity in the fabrication of several orthodontic appliances including retainers. Aim: To evaluate the stability, survival time and periodontal health associated with vacuum-formed retainers (VFRs), bonded retainers (BRs) and rapid prototype retainers (RPRs) over a period of 12 months in retention. Study design: Prospective clinical study. Methods: A total of 72 participants completing fixed orthodontic treatment were allocated to the following three groups by the investigators based upon their initial malocclusion, compliant and preferences: VFR; BR; and RPR. The primary outcome was Little’s Irregularity Index (LII). Other stability parameters, including arch length (AL), inter-canine width (ICW) and inter-molar width (IMW), were also assessed immediately after debonding (T0) and 12 months (T2) after debonding. In addition, survival time, and calculus index and gingival index (GI) were assessed. Results: LII showed a significant difference ( P = 0.00) between the groups and was increased in the VFR group (0.18 ± 0.22 mm) compared to the BR (0.03 ± 0.05 mm) and RPR (0.01 ± 0.03 mm) groups but was not clinically significant. The mean survival time of maxillary retainers was longest for the RPR group (220.63 days; 95% confidence interval [CI] = 194.1–247.16) but there was no significant difference between the three groups ( P = 0.43). The mean survival time of mandibular retainers was higher and the same for the VFR and RPR groups (240 days; 95% CI = 240–240) and there was no significant difference between the three groups ( P = 0.38). The calculus index score ( P = 0.00) was statistically significant between the groups, with an increased score for the BR group (0.33 ± 0.27) compared to the VFR (0.07 ± 0.16) and RPR (0.13 ± 0.22) groups. Similarly, the GI score ( P = 0.02) was statistically significant between the groups and was increased in the BR group (0.01 ± 0.19) compared to the VFR (−0.15 ± 0.18) and RPR (−0.06 ± 0.15) groups. The increase in calculus index and GI scores for the BR group were not clinically significant. Conclusion: There were no clinically significant differences between the three retainer groups in terms of stability, periodontal health and time to failure.

Features of post-surgical menopause with concomitant primary hypothyroidism: A prospective single-stage clinical study

Background. In recent decades, the frequency of surgical interventions on reproductive system organs has been steadily increasing. In gynecological practice, preference is given to minimally invasive surgery and precision treatments, especially involving ovaries. Despite the modern approach, it is not always possible to preserve this endocrine organ, which leads to post-surgical menopause (PSM). The relatively high incidence of total hysterectomy-associated PSM and primary hypothyroidism in late reproductive age often leads to their combination. Clinical manifestations aggravating each other form an unfavorable vicious circle. Aim. To study the features of the PSM course with concomitant primary hypothyroidism. Materials and methods. A prospective clinical study included 130 women aged 45 to 55 years with a history of PSM. The main group consisted of 70 patients with PSM with subclinical primary hypothyroidism. A control group included 60 PSM patients without thyroid disorders. We assessed the effect of hypothyroidism on the PSM course by comparing several indicators in the main and control groups. Results. It was found that in the main group patients, severe 26.5% and moderate 38.8% menopausal syndrome prevailed, while in the control group patients, such forms were twice as common. In the women of the main group, the levels of triglycerides were higher than those in the control group by 1.3 times (2.6±0.86 mmol/L and 1.43±0.33 mmol/L, respectively). The total serum alkaline phosphatase activity in patients in the study groups was 29.8% higher than in healthy women. Conclusion. It can be concluded that the severity of menopausal disorders depends on the thyroid status, with more severe in patients of the main group with hypothyroidism. In addition, in patients of the main group with hypothyroidism, dyslipidemia is more pronounced, which predisposes them to severe diseases in the future, in particular cardiovascular disorders, the unfavorable course of metabolic syndrome, and the development of postmenopausal osteoporosis.

Efficacy of virtual surgical planning and a three-dimensional-printed, patient-specific reduction system to facilitate alignment of diaphyseal tibial fractures stabilized by minimally invasive plate osteosynthesis in dogs: A prospective clinical study.

To evaluate the efficacy of a three-dimensional (3D)-printed, patient-specific reduction system for aligning diaphyseal tibial fractures stabilized using minimally invasive plate osteosynthesis (MIPO). Prospective clinical trial. Fifteen client owned dogs. Virtual 3D models of both pelvic limbs were created. Pin guides were designed to conform to the proximal and distal tibia. A reduction bridge was designed to align the pin guides based on the guides' spatial location. Guides were 3D printed, sterilized, and applied, in conjunction with transient application of a circular fixator, to facilitate indirect fracture realignment before plate application. Alignment of the stabilized tibiae was assessed using postoperative computed tomography scans. Mean duration required for virtual planning was 2.5 h and a mean of 50.7 h elapsed between presentation and surgery. Guide placement was accurate with minor median discrepancies in translation and frontal, sagittal, and axial plane positioning of 2.9 mm, 3.6°, 2.7°, and 6.8°, respectively. Application of the reduction system restored mean tibial length and frontal, sagittal, and axial alignment within 1.7 mm, 1.9°, 1.7°, and 4.5°, respectively, of the contralateral tibia. Design and fabrication of a 3D-printed, patient-specific fracture reduction system is feasible in a relevant clinical timeline. Intraoperative pin-guide placement was reasonably accurate with minor discrepancies compared to the virtual plan. Custom 3D-printed reduction system application facilitated near-anatomic or acceptable fracture reduction in all dogs. Virtual planning and fabrication of a 3D-printing patient-specific fracture reduction system is practical and facilitated acceptable, if not near-anatomic, fracture alignment during MIPO.

CO2 LASER versus Blade Scalpel Surgery in the Management of Nasopharyngeal Masses in Dogs.

We aimed to compare surgical time, bleeding level, patient pain level, healing period, scar tissue, relapse of the initial process and complications in patients with nasopharyngeal oncological masses undergoing surgery using a scalpel blade versus a CO2 surgical laser. This is a clinical prospective study comprising surgical work in the nasopharynx area. A sample of 12 inpatients dogs (N = 12) of both genders underwent a surgical excision of nasopharyngeal masses with a scalpel blade (GS n = 6) and CO2 surgical laser (GL n = 6). An Aesculigth CO2 surgical laser-Vetscalpel® model with a superpulse mode, 12 W of power, and a multi-focus pen was used. Statistically significant differences were registered for a p-value of < 0.05. Variations were noted between both groups (GS and GL) concerning surgery time (p = 0.038), first meal time (p = 0.013), pain level (p = 0.003), and healing time (p = 0.014), with the GL group presenting lower values. GL exhibited only one relapse case, with the elapsed time being more than double that of the GS group. Surgical and healing times were shorter in the GL group, and pain levels were lower, with the GL group also demonstrating less scar tissue than the GS group, along with a lower relapse rate. Nasopharynx surgical exposure with precision via the soft palate using the CO2 laser has facilitated successful treatment of regional masses without discomfort and complications, compared to conventional blade scalpel procedures.

Clinical and Biochemical Effects of Antioxidant Gel as a Local Drug Delivery Agent in Stage II Grade A Periodontitis Patients: A Prospective Clinical Study.

Background Periodontal tissue breakdown is mainly due to pathogenic bacteria and dysregulated immune response resulting in the production of reactive oxygen species/reactive nitrogen species (ROS/RNS) causing tissue degradation. Scaling and root planing (SRP)isusually donefor the management of periodontitis. However,it has been reported thatadjuncts like antibiotics, antiseptics, and antioxidants in the form of local drug delivery enhance the outcome of SRP. Aim The present clinical study aims toexamine the efficacy of an antioxidant oral gel (Bluem®) as a local drug delivery agent adjunct to SRPin the management of stage II grade A periodontitis in terms of clinical and biochemical parameters. Materials and methods The prospective clinical study was conducted among 40 stage II grade A periodontitis patients. The participants were then divided into two groups: Group 1 (Control)-SRP alone (n=20)and Group 2 (Test)-antioxidant gel (Bluem®) with SRP (n=20). Clinical variables including plaque index (PI), gingival index (GI), probing depth (PD), and clinical attachment level (CAL) were recorded. Saliva (unstimulated) specimens were collected to measure total oxidant status (TOS), total antioxidant capacity (TAOC), and oxidative stress index (OSI). Specimen collection and assessment of clinical variables were done before intervention (baseline) and after three months. SPSS Software (Version 20.0, Armonk, NY, USA: IBM Corp) was used for statistical analysis. Intragroup and intergroup comparisons were done by paired t-test and independent t-test, respectively. A p-value <0.05 indicated that the result was statistically significant. Results On intragroup analysis, both the groups at three months revealed statistically significant improvement of PI, GI, PD, CAL, TOS, TAOC, and OSI (p<0.05) from baseline. Intergroup comparison in the third month showed a statistically significant improvement in favor of Group 2 in terms of all the clinical and biochemical parameters (p<0.05) except for PI (p>0.05). Conclusion The locally delivered antioxidant gel as an adjunct to SRP seemsto be effective in reducing oxidative stress and improving the periodontal parameters among stage II grade A periodontitis patients.

Efficacy of intra lesional injection of 5-flourouracil on keloid scar: A prospective open clinical trial

Background and objectives: The management of keloids stayed unsatisfactory. Intralesional 5-fluorouracil has not been broadly and intensively studied as a monotherapy in the treatment of keloids worldwide. So, the aim of this study was to evaluate the efficacy and safety of intralesional injection of 5-flourouracil in patients with keloids. Methods: In this prospective clinical trial study, a total of 20 patients aged &gt;18 years at Shahid Jabar Dermatological Teaching Center, Sulaimaniyah, Iraq, from January 2022 to August 2022 were enrolled. Patients were treated at 1-week interval with intralesional injection of 5-flurouracil (50 mg/mL) at maximum of 6 sessions. Average injection volume was 0.2 mL/cm2. All patients were followed up for 6 months. Results: Most of the patients were aged &lt;50 years (90%) with no family history of keloid (75%). Additionally, 45% of patients had keloid in the trunk region with a size of ?10 cm2 (65%). Most patients (80%) had the disease for ?5 years that caused by inflammation (55%), especially skin type IV (65%). After 6 sessions of treatment, 70% of patients showed moderate improvement, while 30% of patients showed minimum improvement. The main adverse effects after 6 sessions of treatment were hyperpigmentation in 3 patients, bullae in 2 patients, and tissue sloughing only in 1 patient. A significant correlation was found between the patient’s response and age/keloid location. Moreover, mean Redness, Elevation, Hardness, Itching, and Tenderness score after treatment was significantly lower than before treatment (p&lt;0.001). Conclusions: Our results concluded that 5-flurouracil is a safe and effective therapy for the treatment of keloids.

Orofacial esthetics, chewing function, and oral health-related quality of life in Kennedy class I patients with mini-implant-retained removable partial dentures: A 3-year clinical prospective study.

92 participants with posterior edentulism in the maxilla or mandible received 184 MDIs and 92 RPDs. After one year, three participants were excluded, and another seven were excluded after three years. The final sample was 82 participants. Self-perceived orofacial esthetics was assessed by the Orofacial Esthetic Scale (OES), chewing function by the Chewing Function Questionnaire (CFQ), and the OHRQoL by the OHIP-14. Statistical analysis utilized multivariate regression analysis, standardized effect size calculation, Wilcoxon Signed Rank test, and Friedman's test. OHRQoL and chewing function significantly improved (p < 0.001) one month after MDI loading by the new RPDs and continued to improve over the observation period (p < 0.05). The OES also significantly improved (p < 0.001) and remained almost unchanged over the next three years (p = 0.440). Despite the limitations of this study, the MDI-retained RPD appears to be a viable treatment modality in contemporary prosthodontics from the patients' perspective.

PREVECOL, a predictive model for early detection of colorectal cancer and precancerous lesions in liquid biopsy.

3629 Background: Colorectal cancer (CRC) is the second cause of cancer-related deaths worldwide. Most of these deaths could have been prevented by increasing the effectiveness of CRC screening programs, which exhibit a low participation rate, partly due to the limited available screening options, alongside discomfort associated with the screening procedure (faecal test). Liquid biopsy-based technology offers new alternatives to improve CRC early detection. CRC and advanced adenoma (AA) patients show molecular alterations at different biological levels that can be detected in peripheral blood and used for diagnostic purposes. AMADIX has developed PreveCol, an innovative blood test based on molecular biomarkers and clinical features for early detection of CRC and AA, before the onset of the first symptoms. We present the validation of PreveCol predictive model through a European prospective clinical study involving average-risk population actively engaged in a real CRC screening program. PreveCol has been granted with the Breakthrough Device Designation by the FDA in December 2023. Methods: Samples from two prospective clinical studies were used for training and validation. A case-control study (n= 538 individuals: 173 CRC, 181 AA, 184 Controls; 13 Spanish sites) and a clinical study based on a real CRC screening program (n= 3163 individuals: 78 CRC, 156 AA, 146 HRPL, and 2783 Controls; 9 European sites). PreveCol molecular signature (11 proteins and 10 miRNAs), was determined in plasma samples using RT-qPCR and ELISA/CLIA. Machine learning techniques were used to develop an ensemble algorithm. K-fold cross validation techniques were used in the training to set the hyperparameters for each model. Hyperparameter optimalization was performed to find the best parameters of the grid. Once the algorithm was locked and the clinical cut-off was established in the training set, the signature was validated in the European prospective study sub-cohort. Results: For CRC detection, PreveCol demonstrates an Area Under the ROC curve (AUC) of 92%, with a sensitivity (SS) of 81.8% and specificity (SP) of 86%. Moreover, the model exhibits high sensitivity (above 90%) in identifying CRC in early stages (stages 1 and 2), as well as lesions located in the proximal colon. In addition, the AUC of PreveCol for Advanced Adenomas detection is 86.88%, (SS of 70.8% and SP of 86%), showing that PreveCol presents higher sensitivity compared to other identified tests for detecting precancerous lesions. Conclusions: These findings highlight PreveCol's potential to significantly impact on patient prognosis and survival by facilitating the early detection of CRC and premalignant lesions as well as lesions in critical areas of the colon, thereby contributing to improved screening efficacy and patient outcomes.

First-line treatment of EGFR mutation adenosquamous carcinoma of the lung with aumolertinib: A multicenter, single-arm, prospective study (ARISE Study).

e20541 Background: Adenosquamous carcinoma of the lung (ASC), which composed of squamous cell carcinoma and adenocarcinoma, is a rare lung cancer. In Asian population, the mutation rate of epidermal growth factor receptor (EGFR) in ASC is approximately 15.4% to 44%. There were no large prospective clinical studies using EGFR tyrosine kinase inhibitors (TKI) to treat ASC. Methods: We conducted a prospective, multicenter, single-arm clinical trial, designed to evaluate the efficacy and safety of Aumolertinib for ASC patients with EGFR mutations without prior systemic therapy (originally designed as a randomized controlled study versus chemotherapy; the protocol was revised to single-arm study due to insufficient enrollment; Clinical Trial Registry No. NCT04354961). Eligible participants of stage IIIB/IV ASC with EGFR mutations from six Chinese medical centers received Aumolertinib 110mg orally once daily. Follow-up were performed every 6 weeks conducted by independent central review (ICR), based on the RECIST 1.1 criteria. Primary endpoints was progression-free survival (PFS), while secondary endpoints included objective response rate (ORR), disease control rate (DCR), duration of response (DoR) and safety. Results: Of the 18 patients recruited, 12 were evaluated for efficacy and safety. The median follow-up was 13.3 months, with 17 (range 4-26) doses of Aumolertinib treatment. The median PFS was 6.2 months (95% CI 5.0-8.2), while the median OS has not been reached. Of the 12 patients, 7 (58.3%) achieved PR, 3 (25.0%) achieved SD, and 2 (16.7%) were PD. The ICR-confirmed ORR and DCR were 58.3% (95% CI: 62.6%-74.6%) and 83.3% (95% CI: 89.6%-96.2%), respectively. A total of 9 patients (75%) experienced at least one treatment-related adverse events (TRAEs). the most common TRAEs were anemia (27.3%) and elevated aminotransferase (18.2%). three patients (25%) experienced grade 3-4 TRAEs in the form of paralysis, neutropenia and hypokalemia. No treatment-related deaths occurred. Conclusions: This is the first prospective clinical study showing that Aumolertinib is an effective and well-tolerated third-generation EGFR TKI for ASC with EGFR mutations, with favorable ORR and general PFS. In future, head-to-head comparisons of EGFR TKI with chemotherapy and combination therapy would be needed to be explored. Clinical trial information: NCT04354961 .

Impact of cancer screening results on patient-reported outcomes (PRO) and behavioral intentions.

10608 Background: Cancer is one of the most feared diseases. Multi-cancer early detection (MCED) tests have the potential to expand the number of cancers that are detected at earlier stages, which could result in better clinical outcomes. However, behavioral impacts based on MCED test results could affect the utility and value of these tests. Methods: Two independent data sources evaluated the impact of MCED test results on behavioral intentions and perceptions: a survey of the general population and PRO in an MCED clinical trial. A web-based, 30-minute survey of the US general population was used to ascertain attitudes toward a hypothetical MCED test. Eligible respondents were adults aged 40-80 years without a cancer diagnosis in the previous 5 years. The survey assessed the perceived value of negative results (ie, no cancer signal detected [NCSD]) and the projected impact on post-test behaviors. The prospective PATHFINDER study (NCT04241796) of adults aged ≥50 years who underwent MCED cancer screening included PRO assessments. Post-test assessments included: "I am feeling relieved about my test result" from the adapted MICRA and “How likely are you to follow your healthcare provider’s cancer screening recommendations.” The consistency of sentiment after an NCSD MCED result from the online survey and clinical study was assessed. Results: Of the 1073 online survey respondents, 53% were female, 77% White, 14% Black/African American, and 13% Hispanic. Mean age was 58 years. The most common anticipated emotional impacts were relief (84%), happiness (72%), and confidence (69%). Respondents (66-70%) reported they would expect less worry, fear, stress, and anxiety after an NCSD MCED result. The majority (73%) reported they would maintain or improve health behaviors after an NCSD result. NCSD results were projected to lead to an increase in health-related behaviors, including adherence to recommended cancer screening (98%; 68% increase, 30% maintain current level) and regular doctor visits (46%). Of the 6529 PATHFINDER study participants who received NCSD results, 64% were female, 92% White. Mean age was 63 years. 80% of participants (n = 4685/5865) with NCSD felt relief "sometimes" or "often" after their MCED test result. Over 95% of participants (n = 5637/5863) with NCSD indicated they were "likely" or "very likely" to adhere to cancer screening recommendations in the future. Conclusions: Results from a general population survey and a prospective clinical study indicate that an NCSD result may be associated with positive cancer screening intentions and other preventive healthcare behaviors. An NCSD result may also positively impact psychological and emotional health. While these findings suggest that an NCSD result may provide additional value beyond traditional clinical benefits associated with cancer screening, future research is needed to delineate the behavioral impact following MCED screening. Clinical trial information: NCT04241796 .

‘Y’ Modification of the cutaneous incision of the preseptal transconjunctival approach for the management of zygomatico-maxillary complex fractures: A prospective clinical study

AimThe purpose of this clinical study was to evaluate the efficacy of the preseptal transconjunctival approach with Y modification of the cutaneous extension for the management of zygomaticomaxillary complex (ZMC) fractures. MethodsThis prospective interventional study was conducted at our institute from 2012 to 2020. The study included patients aged 15–65 years with displaced ZMC fractures. Patients with uncontrolled systemic conditions, infected and/or comminuted fractures were excluded. The variables evaluated were age, gender, mechanism of injury, fracture side, clinical features, surgical exposure time, adequacy of exposure, complications, scar evaluation scores and cosmetic outcomes. The parameters for comparison were operated versus non operated side Eye Fissure Index (EFI) and surgical exposure time was compared with respect to the types of scars. ResultsA total of 49 patients were included in this study. The average exposure time was 18.87 ± 1.92 min. The exposure of fracture site was excellent in 73.5 % and satisfactory in 26.5 %. The mean EFI of operated side was 34.2 ± 5.04 mm while that of non-operated side was 34.22 ± 5 mm. On comparison of the same there was no significant difference. Invisible scars were noted in 71.4 % and barely visible scars in 22.4 %. The comparison of exposure time with type of scars showed a significant association (p = 0.02). The complications noted were chemosis, lower eyelid edema, conjunctival granuloma and entropion. Cosmetic outcomes were fairly satisfactory. ConclusionThe Y modification of the transconjunctival approach can provide excellent surgical exposure without the need for a second incision. Although this approach is technique sensitive and requires experience, the advantages outweigh the learning curve. Since this approach has been widely studied, a systematized review is recommended to further substantiate its reliability and advantages.

Impact of chemotherapy-induced peripheral neuropathy permanence on patients' preference to discontinue chemotherapy.

12046 Background: Chemotherapy-induced peripheral neuropathy (CIPN) diminishes patients’ functional ability and quality of life; approximately 40% of patients experience CIPN symptoms 3 years after treatment. Due to the absence of effective CIPN treatments, ASCO guidelines recommend discontinuing chemotherapy in patients experiencing intolerable CIPN symptoms. Little is known about patient’s preference to continue or discontinue chemotherapy when experiencing CIPN, and whether the potential permanence of CIPN symptoms affects this decision. The objective of this prospective observational study was to determine the effect of CIPN symptom permanence on patients’ preference to discontinue chemotherapy. Methods: Patients receiving taxane and/or platinum chemotherapy for breast or colorectal cancer were enrolled in a prospective observational clinical study. Patients reported their CIPN severity using the EORTC CIPN20 patient-reported outcome questionnaire at the start of each treatment cycle. At the same time, patients were asked if they would prefer to continue or discontinue chemotherapy treatment under the hypothetical scenario that their current CIPN symptoms would be temporary or permanent. A generalized linear mixed effects model was used to determine the effect of CIPN severity, permanence, and other clinical variables on a patient’s decision to discontinue (vs. continue) chemotherapy treatment. Results: A total of 66 patients completed data collection at least one time, of whom 55 (83%) had breast cancer, 12 (18%) had metastatic disease, and 52 (79%) received a taxane. The odds a patient would prefer to discontinue chemotherapy treatment if their CIPN symptoms would be permanent (vs. temporary) were nearly 30 times greater (odds ratio (OR)=30.15, 95% confidence interval (CI): 15.73-57.79, p&lt;0.001, Table). There was a statistical trend toward preferring to discontinue chemotherapy treatment as CIPN symptom severity increased (OR=1.09, 95% CI: 1.00-1.19, p=0.063). Conclusions: The potential for CIPN symptoms to be permanent has a huge effect on whether patients want to continue or discontinue chemotherapy treatment. Additional data is needed on the incidence and predictors of permanent CIPN. More importantly, shared decision-making tools that convey the risk of permanent CIPN, and the potential risk of discontinuing chemotherapy treatment, are needed to facilitate patient-centered treatment decisions so that each patient with cancer achieves their personal treatment goals. [Table: see text]

Sequential neoadjuvant chemotherapy for borderline resectable and locally advanced pancreatic adenocarcinoma.

TPS4209 Background: Patients with borderline resectable (BRPC) and locally advanced unresectable (LAPC) pancreatic cancer have a median OS of 8-20 months unless they undergo margin negative resection. Despite advances in systemic therapy, the prognosis is dismal. The locoregional and distant failure rates are high in post-surgery and therefore neoadjuvant chemotherapy emerged as standard-of-care practice to select the patients for surgery and improve overall clinical outcomes. An effective and tolerable neoadjuvant regimen can facilitate R0 resection by tumor down staging and mitigating the risk for positive margins. A recent SEQUENCE-2 study on sequential treatment with combination of Gemcitabine and nab-paclitaxel (GA) GA followed by modified FOLFOX (mFOLFOX) improved OS (13.2 months) and PFS (9.5 months) in patients with metastatic PDC, compared with the standard GA regimen, with comparable safety profile. Current guidelines suggest modified FOLFIRINOX (mFFX, infusional 5-fluorouracil, oxaliplatin, irinotecan) or GA as the first-line systemic chemotherapeutic regimen in neoadjuvant, adjuvant and palliative setting. These regimens are associated with modest pathological complete response rate. However, there is significant unmet need for management of BRPC and LAPC as the optimal treatment strategy remains undefined. As both of the aforementioned regimens are active and feasible in BRPC and LAPC, we conceptualize that by using both regimens alternating in sequence the rate of R0 resection and pathological response could be improved by overcoming possible resistance to a single backbone. Methods: The aim of this study is to demonstrate the efficacy and feasibility of sequential chemotherapy (GA followed by mFFX) in patients with BRPC (n=34) and LAPC (n=30). To achieve this, we are conducting a non-randomized prospective interventional clinical study with BRPC and LAPC patients treated with alternating cycles of GA and mFFX for 4 months and assessed for clinical outcomes, feasibility and toxicity. The primary objective of this study is to evaluate the efficacy of sequential GA followed by mFFX in improving R0 resection rate in patients with BRPC and LAPC. After four months of sequential neoadjuvant therapy, the patients will proceed to surgery, radiation, or extended course of chemotherapy, off study, as determined by multidisciplinary tumor board consensus or the treating physician. These results will have high translational potential for providing mechanistic insight into tumor response, optimizing current management strategies for pancreatic cancer that could be generalizable to other stages of this cancer. The key eligibility criteria include treatment naive histologically diagnosed BRPC or LAPC with measurable disease, ECOG 0,1, optimal organ function. Clinical trial information: NCT05776524 .

A prospective double-blind clinical study: Effect of probiotics and thalidomide on radiation enteritis in patients with pelvic cancer undergoing concurrent chemoradiotherapy.

e23013 Background: Radiation induced diarrhea (RID) is one of the commonest and most distressing side effects during and after radiotherapy predominantly in patients whose irradiation region is pelvis. Thalidomide reduces severity as well as the frequency indicated in RID but mechanism of action is not elucidated. Probiotics are beneficial microorganisms that may regulate flora of intestines to increase immunity and have a protective effect on RID. This pilot study was designed to ascertain effects of thalidomide and probiotics on RID in patients being subjected to pelvic irradiation. Methods: A double-blind, single-center, randomized pilot study was conducted. Patients were classified into two groups as thalidomide plus probiotics (Lactobacillus rhamnosus + Probio-M9, ) group (TP group) or plus placebo group (P group).Incidence of grade 3/4 diarrhea, was a primary endpoint of the study. Other secondary endpoints analyzed were rates and severity of diarrhea, antibiotics use, body weight, albumin, and lymphocyte changes. 31 patients undergoing pelvic radiotherapy with or without concurrent chemotherapy were randomly selected from government tertiary general hospital. Results: The incidence of grade 3/4 diarrhea was 9.5% (95% CI: 0 to 24.5%) in TP, which was significantly different from historical data of 30% to 60%. The incidence of grade 3/4 diarrhea in group P was 19.8% (95% CI: 0~41.3%). The frequency and severity of diarrhea in group TP were little less than in group P. There is no significant difference between them. Basically, the time for antibiotic use in groups P and TP was the same, with a slightly longer time from first antibiotic exposure in group TP as compared to group P. The moment of first antibiotics have been prescribed in our study patients, this was better than that of a clinical routine treatment experience and other research data according to the literature. The changes in body weight, albumin level, and lymphocyte at different stages before and after radiotherapy in group TP were not statistically significant, and the level of body weight and albumin in group P was slightly reduced compared with before radiotherapy but increased compared with group TP after radiotherapy. Furthermore, there were no severe adverse effects regarding thalidomide as well as probiotics reported among patients who participated in this study. Conclusions: The combined treatment with thalidomide and probiotics is beneficial to ameliorate RID in patients receiving pelvic radiotherapy, yet this study can't represent whole conclusion due to small size of patients. We will also need larger, multicenter double-blind placebo-controlled trials to confirm exact efficacy and safety of this combined treatment. Clinical trial information: NCT05059613 .

Long-term Effects of COVID-19 on Vascular Parameters: A Prospective Longitudinal Ultrasound Clinical Study for CME Credit June 2024

Long-term Effects of COVID-19 on Vascular Parameters: A Prospective Longitudinal Ultrasound Clinical Study for CME Credit June 2024