Cancer Antigen Research Articles

Machine learning models in evaluating the malignancy risk of ovarian tumors: a comparative study.

The study aimed to compare the diagnostic efficacy of the machine learning models with expert subjective assessment (SA) in assessing the malignancy risk of ovarian tumors using transvaginal ultrasound (TVUS). The retrospective single-center diagnostic study included 1555 consecutive patients from January 2019 to May 2021. Using this dataset, Residual Network(ResNet), Densely Connected Convolutional Network(DenseNet), Vision Transformer(ViT), and Swin Transformer models were established and evaluated separately or combined with Cancer antigen 125 (CA 125). The diagnostic performance was then compared with SA. Of the 1555 patients, 76.9% were benign, while 23.1% were malignant (including borderline). When differentiating the malignant from ovarian tumors, the SA had an AUC of 0.97 (95% CI, 0.93-0.99), sensitivity of 87.2%, and specificity of 98.4%. Except for Vision Transformer, other machine learning models had diagnostic performance comparable to that of the expert. The DenseNet model had an AUC of 0.91 (95% CI, 0.86-0.95), sensitivity of 84.6%, and specificity of 95.1%. The ResNet50 model had an AUC of 0.91 (0.85-0.95). The Swin Transformer model had an AUC of 0.92 (0.87-0.96), sensitivity of 87.2%, and specificity of 94.3%. There was a statistically significant difference between the Vision Transformer and SA, and between the Vision Transformer and Swin Transformer models (AUC: 0.87 vs. 0.97, P = 0.01; AUC: 0.87 vs. 0.92, P = 0.04). Adding CA125 did not improve the diagnostic performance of the models in distinguishing benign and malignant ovarian tumors. The deep learning model of TVUS can be used in ovarian cancer evaluation, and its diagnostic performance is comparable to that of expert assessment.

Case report: Efficacy of later-line fam-trastuzumab deruxtecan in a patient with triple-positive breast cancer with brain metastases

Fam-trastuzumab deruxtecan (T-DXd) has demonstrated substantial antitumor activity and durable responses in patients with human epidermal growth factor receptor 2 positive (HER2+) metastatic breast cancer. We report here the treatment outcomes of T-DXd in a patient with HER2+ breast cancer with brain metastases that repeatedly recurred and progressed after two lines of salvage therapy. In 2016, a 23-year-old G0P0 female with risk factors including menarche at age 9 years, Li-Fraumeni syndrome, and a strong family history of cancer was diagnosed with bilateral, triple-positive breast cancer. She received chemotherapy, HER2-targeted therapies, total mastectomy, and locoregional radiotherapy, but a brain metastasis in the left parieto-occipital lobe was detected in 2020. After receiving capecitabine, lapatinib, gonadotropin-releasing hormone (GnRH) agonist, and tamoxifen, multiple new lesions appeared in the brain after 14 months. The patient then received capecitabine, neratinib, GnRH agonist, and letrozole; however, her brain metastases still progressed after 7 months. In 2022, she started T-DXd treatment. Good response to treatment was observed 4 months later, including a continuous decrease in the cancer antigen 15-3 level, a reduction in the size of the major brain tumor, and the absence of new lesions. Now aged 30, the patient is continuing to receive T-DXd treatment to prevent recurrence. We conclude that T-DXd was effective for the treatment of brain metastases in this young patient with triple-positive metastatic breast cancer who had multiple risk factors and had received several anti-HER2 therapies prior to T-DXd.

Biomarkers of rheumatoid arthritis-associated interstitial lung disease: a systematic review and meta-analysis

BackgroundInterstitial Lung Disease (ILD) represents the most common extra-articular manifestation of Rheumatoid Arthritis (RA) and is a major cause of mortality. This study aims to identify and evaluate biomarkers associated with Rheumatoid Arthritis-Associated Interstitial Lung Disease (RA-ILD).MethodsWe searched PubMed, Cochrane Library, EMBASE, and Web of Science databases for studies related to biomarkers of RA-ILD up until October 7, 2023. The Newcastle-Ottawa Scale (NOS) and standards recommended by the Agency for Healthcare Research and Quality (AHRQ) were used for quality assessment, and meta-analysis was conducted using Stata18.0 software.ResultsA total of 98 articles were assessed for quality, 48 of which were included in the meta-analysis. 83 studies were of high quality, and 15 were of moderate quality. The meta-analysis showed significant differences in biomarkers such as C-Reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), Anti-Cyclic Citrullinated Peptide (anti-CCP) antibody, Rheumatoid Factor (RF), Krebs von den Lungen-6 (KL-6), Surfactant Protein D (SP-D), Carcinoembryonic Antigen (CEA), Carbohydrate Antigen 19-9 (CA19-9), Matrix Metalloproteinase-7 (MMP-7), C-X-C Motif Chemokine Ligand 10 (CXCL-10), and Neutrophil-to-Lymphocyte Ratio (NLR) between RA-ILD patients and RA patients. However, Platelet-to-Lymphocyte Ratio [Platelet-to-Lymphocyte Ratio (PLR)], Cancer Antigen 125 [Cancer Antigen 125 (CA-125)], and Cancer Antigen 153 [Cancer Antigen 153 (CA-153)] did not show significant differences between the two groups. KL-6, MMP-7, and Human Epididymis Protein 4 (HE4) are negatively correlated with lung function, and KL-6 is associated with the prognosis of RA-ILD.ConclusionsBiomarkers hold promising clinical value for prediction, diagnosis, severity assessment, and prognosis evaluation in RA-ILD. However, these findings need to be validated through multicenter, large-sample, prospective cohort studies.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/, identifier CRD42023448372.

BRCA Mutation in Ovarian Cancer: Implications for Screening, Diagnosis, and Preventive Measures

Ovarian cancer is the most common gynaecological malignancy and the seventh most common malignancy in women. Inherited ovarian cancer is caused by mutations in certain genes, such as BRCA1 and BRCA2, as well as many minor genes. The pathology of ovarian cancer involves damage to the cell cycle mechanism secondary to mutations in BRCA1/2 protective genes. These mutations provide a meaningful marker for screening and diagnosing hereditary ovarian cancer. Classification of ovarian cancer is based on histology, depending on which layers of the ovary are affected. The authors conducted an electronic search using keywords and selected the included studies based on pre-established inclusion criteria. To avoid bias in the data extraction process, three reviewers extracted information independently. Risk assessment models provided by the National Comprehensive Cancer Network (NCCN) and American College of Obstetricians and Gynecologists (ACOG) are mostly used in clinical practice. The combination of serial serum cancer antigen-125 (CA-125) levels and transvaginal ultrasound is the only evidence-based screening approach available to patients at increased risk for ovarian cancer. Strong evidence has made salpingo-oophorectomy the gold standard for risk-reducing surgery. Bilateral salpingectomy, in contrast, is restricted to clinical trials currently. The protective effects of oral contraceptives have made them suitable agents for chemoprevention. Whilst the potential benefits of aspirin and certain other drugs have been investigated, further research is required to address the gap in data for them to be used in clinical practice for the purpose of ovarian cancer prevention.

Cohort study of serological biomarkers for interstitial lung disease in patients with rheumatoid arthritis

Objective Interstitial lung disease (ILD) is an important cause of mortality in patients with rheumatoid arthritis (RA). Early RA-ILD detection is essential to improve prognosis. Here, we investigated eight serological biomarkers that may contribute to RA-ILD detection. Method Fifty-five patients from the Early Rheumatoid Arthritis Program were evaluated for ILD with high-resolution computed tomography (HRCT) and pulmonary function tests (PFTs) using the SCAPIS protocol. Blood samples were obtained for biomarker analysis, and patients’ clinical records were reviewed. We defined ILD using five different models based on the measurements used to confirm ILD: Model A = HRCT; B = PFTs; C = A plus B; D = C plus symptoms; and E = D plus inhalations. Results Among 55 patients, two had an ILD diagnosis before the study, but over one-third fulfilled the ILD criteria. Cancer antigen 15-3 (CA15-3) and matrix metalloproteinase-7 (MMP-7) differentiated between RA with and without ILD (all p < 0.05). Surfactant protein D (SP-D) showed similar trends, as did macrophage inflammatory protein-1β (MIP-1β) and chitinase 3-like protein-1 (YKL-40). Based on Pearson’s correlation coefficients, MIP-1β and YKL-40 were significantly correlated with DAS28 (MIP-1β: 0.3; YKL-40: 0.4), ESR (MIP-1β: 0.3; YKL-40: 0.4), and CRP (only MIP-1β: 0.4) (all p < 0.05). CA15-3 was correlated with rheumatoid factor and anti-citrullinated peptide antibodies (Pearson’s correlation 0.3; both p = 0.03). Conclusions CA15-3 was the most significant biomarker for ILD detection in RA patients with stable low disease activity, closely followed by MMP-7. SP-D, MIP-1β, and YKL-40 may also contribute to RA-ILD diagnosis.

Living From Test to Test: A Concept Analysis of CA-125 Preoccupation in Ovarian Cancer Survivorship

Background: Ovarian cancer has a high risk of recurrence and is rarely curable. One method for monitoring recurrence is trending Cancer antigen 125 (CA-125) levels. However, treatment based on rising CA-125 levels is controversial, often contributing to anxiety and an excessive focus on test results, described as “CA-125 preoccupation.” Objective: To present an analysis on the concept of CA-125 preoccupation. Methods: Rodgers’ method of evolutionary concept analysis was used to evaluate the attributes, antecedents, and consequences. PubMed, Medline, PsycINFO, and CINAHL electronic databases were searched. Results: Antecedents include a diagnosis of ovarian cancer that necessitates CA-125 surveillance, awareness of CA-125 as a tumor marker, and perceived disease status. Attributes include psychosocial symptoms characterized by a fixation with CA-125 levels and symptoms of anxiety, depression, distress, and illness intrusiveness that present in a cyclical pattern. Consequences include urgency to treat rising levels and surveillance and survivorship care preferences. Conclusions: CA-125 preoccupation is characterized by psychosocial symptoms that present in a cyclical and dynamic state akin to living “test to test” or feeling suspended in a perpetual cycle of tests, driven by a desire to feel relief or prompt action. Implications for Practice: Nurses are poised to influence the patient’s experience through identification of the presence of CA-125 preoccupation and its consequences. Understanding the antecedents and attributes of CA-125 may assist with identifying women who are most at risk. What is Foundational: This research presents the first known conceptual definition of CA-125 preoccupation, which may lead to validated survey measures and improved survivorship care.

Efficacy of total laparoscopic hysterectomy without uterine manipulators in patient with early-stage cervical cancer

Objective: To evaluate the feasibility and safety of total laparoscopic hysterectomy (TLH) without uterine manipulator for patients with early-stage cervical cancer. Methods: This study was based on retrospective analysis of clinical data of 72 patients with early-stage cervical cancer who received TLH treatment in Meizhou People’s Hospital from January 2018 to December 2020. Of them, 40 patients underwent routine TLH (control group), and 32 patients received TLH without lifting the uterus using uterine manipulator (observation group). Changes in tumor marker levels, human papilloma virus (HPV) status, complications, and survival between two groups of patients were compared. Results: There was no significant difference in the incidence of postoperative complications between the two groups (P&gt;0.05). After the surgery, levels of squamous cell carcinoma antigen (SCC-Ag), carcinoembryonic antigen (CEA), and cancer antigen 125 (CA-125) in both groups of patients were significantly reduced compared to before the surgery, and significantly lower in the observation group compared to the control group at one and two years after the surgery (P&lt;0.05). After three years of postoperative follow-up, there was no significant difference in cumulative survival rates between the two groups (P&gt;0.05). Conclusions: Compared with conventional laparoscopy, hysteroscopy without the use of uterine manipulators can significantly reduce the levels of SCC-Ag, CEA, and CA-125 in patients with early-stage cervical cancer within two years after the surgery, without increasing postoperative complications or affecting survival, and has the same safety. doi: https://doi.org/10.12669/pjms.40.10.10093 How to cite this: Chen Q, Chen Q, Yang H, Dai S. Efficacy of total laparoscopic hysterectomy without uterine manipulators in patient with early-stage cervical cancer. Pak J Med Sci. 2024;40(10):2428-2431. doi: https://doi.org/10.12669/pjms.40.10.10093 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Anticancer Effects of Weizmannia coagulans MZY531 Postbiotics in CT26 Colorectal Tumor-Bearing Mice by Regulating Apoptosis and Autophagy

Weizmannia coagulans has been shown to have anticancer properties. However, there is limited research on the effects of postbiotic W. coagulans on colorectal cancer cell proliferation. Additionally, the exact mechanisms through which it influences apoptosis- and autophagy-related signaling pathways are yet to be thoroughly elucidated. This study explored the role of W. coagulans MZY531 as a postbiotic in inhibiting tumor growth by modulating apoptosis and autophagy in tumor cells. During the experimental period in the model group, tumors proliferated, tumor markers increased significantly, and immunofluorescence results showed that caspase-3 and terminal deoxynucleotidyl transferase dUTP nick-end labeling were significantly decreased. Conversely, supplementation with W. coagulans MZY531 postbiotics significantly reduced the levels of tumor markers carcinoembryonic antigen, colon cancer antigen, and extracellular protein kinase A and promoted cell apoptosis by increasing the caspase-3-positive count and terminal deoxynucleotidyl transferase dUTP nick-end labeling-positive cells in tumor tissue. Mechanistically, W. coagulans MZY531 postbiotics inhibit tumor growth through the modulation of the Bax/Bcl-2/caspase-3 and JAK2/STAT3 apoptosis pathways and PI3K/AKT/mTOR and TGF-β/SMAD4 cell autophagy pathways. W. coagulans MZY531 postbiotics had a more significant effect than that of W. coagulans MZY531 alone. Probiotics are expected to become effective natural functional foods for the treatment of colorectal cancer.

Roles of microRNA-486-5p in the diagnosis and the association with clinical symptoms of cervical cancer.

Aim: To explore the predictive value of miR-486-5p in early cervical cancer and the associations of miR-486-5p with different clinical symptoms.Materials & methods: A total of 185 women were recruited. The relative expression levels of serum miR-486-5p were analyzed by real-time polymerase chain reaction. The receiver operator characteristic curves were utilized to reflect the predictive performance of miR-486-5p and squamous cell carcinoma antigen for early cervical cancer. Univariate logistic regression and ranked logistic regression were used to explore the associations of miR-486-5p with different clinical symptoms of early cervical cancer, with odd ratios (ORs) and 95% confidence intervals.Results: Eighty-one women (44.26%) had early cervical cancer. The relative expression of serum miR-486-5p was 1.99-fold higher in early cervical cancer patients than that in controls (p<0.0001). The predictive performance of miR-486-5p for early cervical cancer was significantly superior to that of squamous cell carcinoma antigen, with an area under the curve of 0.865 (p<0.001), sensitivity of 1.000and specificity of 0.804. In addition, overexpressed miR-486-5p was associated with high odds of maximum tumor diameter increase (OR=1.30, 95%CI: [1.01-1.66]).Conclusion: MiR-486-5p may be a potential biomarker for the early cervical cancer diagnosis, and was linked to the risk of maximum tumor diameter.

Struma Ovarii- Association with Pseudo-Meigs Syndrome and Raised S. CA-125: A Case Report

The monodermal mature teratoma known as Struma Ovarii is a rare and uncommon form of ovarian tumours. It is primarily composed of thyroid tissue and is associated with hyperthyroidism, increased levels of S. CA-125 (Cancer Antigen-125), and pseudo-Meigs syndrome. Because the symptoms of this tumour are nonspecific, other extremely frequent ovarian lesions may be misdiagnosed and ignored. The majority of the time, incidental imaging and symptoms are used to make the first diagnosis of the cancer; histopathology is used to confirm the diagnosis. A good prognosis and successful curative treatment can result from surgically removing the tumour. The tumour's rarity makes misdiagnosis frequent. Nonetheless, a total abdominal hysterectomy combined with a bilateral salpingo-oophorectomy may be indicated in premenopausal patients in order to eradicate all symptoms. Ascites, hyperthyroidism, high S. CA-125 levels, and hydrothorax are all rare outcomes of struma ovarii. In this uncommon syndrome with negative cytology, individuals with ascites and pleural effusion should be examined for a differential diagnosis. Bangladesh Armed Forces Med J Vol 57 No (1) June 2024, pp 50-55

Characteristics and risk factor analyses of high-grade intraepithelial neoplasia in older patients with colorectal polyps.

According to the degree of intradermal neoplasia in the colorectal exhalation, it can be divided into two grades: Low-grade intraepithelial neoplasia (LGIN) and high-grade intraepithelial neoplasia (HGIN). Currently, it is difficult to accurately diagnose LGIN and HGIN through imaging, and clinical diagnosis depends on postoperative histopathological diagnosis. A more accurate method for evaluating HGIN preoperatively is urgently needed in the surgical treatment and nursing intervention of colorectal polyps. To explore the characteristics and risk factors of HGIN in older patients with colorectal polyps. We selected 84 older patients diagnosed with HGIN as the HGIN group (n = 95 colonic polyps) and 112 older patients diagnosed with LGIN as the LGIN group (n = 132 colonic polyps) from Shandong Provincial Hospital Affiliated to Shandong First Medical University. The endoscopic features, demographic characteristics, and clinical manifestations of the two patient groups were compared, and a logistic regression model was used to analyze the risk factors for HGIN in these patients. The HGIN group was older and had a higher number of sigmoid colon polyps, rectal polyps, pedunculated polyps, polyps ≥ 1.0 cm in size, polyps with surface congestion, polyps with surface depression, and polyps with villous/tubular adenomas, a higher proportion of patients with diabetes and a family history of colorectal cancer, patients who experienced rectal bleeding or occult blood, patients with elevated carcinoembryonic antigen (CEA) and cancer antigen 199 (CA199), and lower nutritional levels and higher frailty levels. The polyp location (in the sigmoid colon or rectum), polyp diameter (≥ 1.0 cm), pathological diagnosis of (villous/tubular adenoma), family history of colorectal cancer, rectal bleeding or occult blood, elevated serum CEA and CA199 levels, lower nutritional levels and higher frailty levels also are independent risk factors for HGIN. The occurrence of high-grade neoplastic transformation in colorectal polyps is closely associated with their location, size, villous/tubular characteristics, family history, elevated levels of tumor markers, and lower nutritional levels and higher frailty levels.

Factors Influencing Postoperative Recurrence and Live Birth Achievement after Laparoscopic Surgery for Ovarian Endometrioma: A Retrospective Study in a Regional Core Hospital

Background: Ovarian endometrioma (OMA) is a common gynecological condition affecting women of reproductive age, often requiring laparoscopic surgery for removal. However, the management of OMA, including postoperative hormone therapy, is complex and must be tailored to the individual's conditions. Therefore, to provide meaningful insights, we aimed to analyze 10 years of accumulated data from patients who underwent laparoscopic surgery for OMA, with a primary focus mainly on postoperative OMA recurrence and live birth outcomes. Methods: We reviewed the medical records of 158 patients who underwent laparoscopic surgery for OMA, including total laparoscopic cystectomy (TLC) (79 patients), total laparoscopic adnexectomy (TLA) (62 patients), or both unilateral TLA and contralateral TLC (17 patients), between January 2014 and December 2023. Among the OMA patients, we identified 7 cases of postoperative OMA recurrence out of 158 patients, and 23 live births among 79 TLC patients. We performed a multivariate logistic regression analysis to assess the impact of each representative factor on postoperative OMA recurrence and live birth achievement. Results: The multivariate analyses of the 158 patients revealed that advance age and massive blood loss were significantly associated with an increased risk of postoperative OMA recurrence, while postoperative hormone treatment was associated with a decreased risk of recurrence. In the analysis of live birth achievement among the 79 TLC patients, advanced age, postoperative hormone treatment and cancer antigen 125 (CA125) positivity were significantly associated with a reduced likelihood of achieving live birth. Conclusions: Our data highlight the unfavorable effects of advanced age, massive blood loss and CA125 positivity on the outcomes of laparoscopic surgery for OMA. Additionally, postoperative hormone treatment was found to decrease postoperative OMA recurrence. These findings may offer more accurate information to guidance in selecting treatment options for patients with OMA.

Immunological tolerance in breast cancer: some reasons for development

Immunological tolerance is one of the reasons for the development and progression of malignant tumors. The tumor immune cycle regulates the normal antitumor immune response, and it’s disruption is responsible for the development of immunological tolerance. This article provides a review of russian and foreign literature published in databases such as PubMed, Medline, and Cochrane, eLibrary in the last 5 years, focusing on the emergence of immunological tolerance in breast cancer from the perspective of disrupted regulation of tumor immune cycle phases: expression of antigens on the surface of tumor cells, cancer antigen presentation, priming and activation T cells, immune infiltration of the tumor site, recognition, and elimination of tumor cells. Understanding the mechanisms underlying tumor immune cycle disruption is important for identifying new immunopathogenetic links in the development of breast cancer, as well as identifying targets to improve the effectiveness of therapy for advanced breast cancer.

The association among cancer-antigen-125 and pre-eclampsia and estimated fetal weight: A case-control study.

Although an optimal screening model is still under investigation, pre-eclampsia is a leading cause of perinatal morbidity. The association between cancer-antigen-125 (CA-125) and pre-eclampsia has been discussed in several studies recently. We aimed to determine the association between CA-125 and preeclampsia and estimated fetal weight. This case-control study was performed on 30 pregnant women with pre-eclampsia who were homogenized in terms of age, body mass index, and gestational age with 30 normal pregnant women. Participants were recruited via convenience sampling. The level of CA-125 in blood at the time of termination of pregnancy was measured by Enzyme Linked Immunosorbent Assay. The urine sample was used to check proteinuria. Blood pressure and pregnancy outcomes were assessed and recorded. The mean serum CA-125 level in study group was considerably higher than control group (p 0.001). Elevating the level of CA-125 has increased the likelihood of pre-eclampsia by 1.5 times. A significant direct correlation was obtained between CA-125 level and the amount of urinary protein (r = 0.605, p 0.001). Also, a significant but negative correlation was obtained between the CA-125 level and the estimated weight of the fetus (r = -0.593, p 0.001). Increasing the serum level of CA-125 with high sensitivity and specificity is significantly associated with the occurrence of pre-eclampsia and estimated fetal weight.

THE ROLE OF CA 19.9 IN PREDICTING THE OPERABILITY OF CARCINOMA PANCREAS

Objectives: Adenocarcinoma of the pancreas remains a relatively incurable disease despite advances in surgical care. Approximately 25% of patients will be found to have unresectable tumors during surgery even though computed tomography (CT) has demonstrated that they are resectable. There is a controversy regarding the use of cancer antigen 19-9 (CA 19-9) to decide the resectability of pancreatic adenocarcinoma [1]. Our aim is to study the use of CA 19-9 in determining the operability of carcinoma pancreas [2]. Methods: This was a prospective study which included 69 patients and the study period was from December 2021 to December 2022. Data were collected from all patients with carcinoma of the pancreas who underwent surgical management. CA 19-9 levels were measured and recorded [3]. During surgery, the operative findings on resectability were documented and tabulated against corresponding CA 19-9 levels and contrast-enhanced CT (CECT) findings. Results: Of the 69 patients who were operated on, 38 patients had resectable tumors and underwent the Whipples procedure and 31 of them had non-resectable tumors and had to undergo palliative bypass procedures. Among the 31 patients whose tumors were non-resectable, only four were diagnosed non-resectable preoperatively with CECT, and the other 27 were found to be non-resectable only during surgery. That shows the relevance of this study. Of the 31 non-resectable cases, 14 (45.2%) patients had elevated CA 19-9 values of more than 501, and the rest 17 (54.8%) patients had low CA 19-9 values. Among the 38 resectable cases, 12 patients (31.6%) had elevated CA 19-9 more than 501, and 26 patients (68.4%) had low values. In conclusion, among non-resectable cases, 45.2% had raised CA 19-9, and among operable cases, 31.6% showed raised CA 19-9. Hence, CA 19-9 seems to be an insignificant predictor of tumor resectability [4]. Conclusion: It was found that the need for a pre-operative predictor for resectability of carcinoma pancreas is relevant while considering mortality and morbidity in operating carcinoma pancreas cases. On evaluating CA 19-9 as a pre-operative predictor, we found that CA 19-9 has no significant role as an indicator of local advancement or metastasis. Hence, we cannot consider CA 19-9 as a predictor of resectability of carcinoma pancreas preoperatively [5].

6485 Unilateral Adrenal Metastasis From Unknown Primary Carcinoma Mimicking Primary Adrenocortical Carcinoma

Abstract Disclosure: S. Watanabe: None. S. Suzuki: None. K. Ishiwata: None. Y. Yamazaki: None. H. Sasano: None. K. Yokote: None. Background: Adrenal metastasis from carcinomas of the lung, breast, and melanoma are observed. However, isolated adrenal metastasis with unknown primary carcinoma origin has been rare, and the diagnosis is challenging. We encountered a case of unilateral adrenal tumor clinically diagnosed as non-functional primary adrenocortical carcinoma, but found to be a metastatic tumor on postoperative pathology. Clinical Case: A 68-year-old man was referred to our hospital for examination of an 8mm right adrenal incidentaloma. He underwent hormone therapy for prostate cancer four years ago, and the condition is in remission with no recurrence signs. Follow-up CT revealed that the adrenal tumor rapidly enlarged from 8 mm to 36 mm within six months, and its mean attenuation value was 38 HU. MRI showed that the adrenal tumor had a low signal intensity on T1 and a high signal on T2. At the same time, there is mediastinal lymphadenopathy and a 9-mm nodule in the lower lobe of the right lung, which was considered benign from the stable condition. FDG-PET/CT showed FDG uptake only in the right adrenal tumor (maximum standardized uptake value of 21.39). [1]23I-MIBG scintigraphy did not show any accumulations. The serum and urinary adrenal hormones were all within normal limits. Notably, tumor markers such as prostate-specific antigen (PSA), carcinoembryonic antigen (CEA), α-fetoprotein (AFP), and cancer antigen 19-9 (CA 19-9) were all within normal ranges. Therefore, we clinically suspected non-functional primary adrenocortical carcinoma, and the laparoscopic right adrenalectomy was performed. The resected right adrenal lesion was encapsulated and measured 79×54×22 mm. On histological analysis, the nodule comprised tumor cells with eosinophilic cytoplasm, and abundant tissue infiltrating lymphocytes. Immunohistochemical studies revealed that the tumor was not of adrenal origin due to negative steroidogenic factor-1 (SF-1) and inhibin alpha staining. From these results, the adrenal tumor was diagnosed as adrenal metastasis from unknown primary carcinoma. The tumor cells were positive for cytokeratin19, CEA, and thyroid transcription factor-1 but negative for PSA, p63, cytokeratin 5/6, insulinoma-associated protein-1, and synaptophysin. Genetically, the adrenal tumor harbored genomic abnormalities in CDKN2A, TP53, NF1, PBRM1, and KEAP1 genes. Conclusion: Isolated adrenal metastasis without a detectable primary tumor is rare but should be considered a differential diagnosis in the case of an enlarged, non-functioning adrenal tumor. Adrenalectomy or tumor biopsy may be actively considered to diagnose and determine the optimal course of treatment. Presentation: 6/3/2024

Predictors of encapsulated peritoneal sclerosis in patients undergoing peritoneal dialysis using neutral-pH dialysate.

Encapsulated peritoneal sclerosis (EPS) is a serious complication in patients undergoing peritoneal dialysis (PD). Neutral-pH dialysate is associated with less peritoneal damage and a lower incidence of EPS than conventional PD solution. However, monitoring for peritoneal damage and predicting EPS remain important during PD therapy. We measured the mesothelial cell area, dialysate-to-plasma ratio of creatinine after 4h, and concentrations of the potential biological markers effluent fibrin degradation products (eFDPs), cancer antigen-125, and interleukin-6 in the effluent dialysate from patients who had been undergoing PD therapy for > 5years in our hospital. These biomarkers were obtained from the drainage fluid of the final measurement of peritoneal equilibration testing before withdrawal from PD therapy. The concentrations of these potential biomarkers were measured in 39 patients who withdrew from PD therapy and were enrolled in the study. Three participants developed EPS after withdrawing PD. The dialysate-to-plasma ratio of creatinine, area of mesothelial cells, and interleukin-6 appearance rate in participants who developed EPS tended to be higher than those in patients who did not, but there were no significant differences. Significantly more eFDPs were in participants who developed EPS than in those who did not (138.5 ± 15.1 vs. 32.9 ± 7.4µg/mL, P = 0.002). There was no difference in the cancer antigen-125 appearance rate between the groups. A cut-off value of eFDPs ≥ 119.1µg/mL was optimal for predicting EPS (P = 0.006, specificity = 0.972, sensitivity = 1.000). This study shows that eFDPs may be a useful biological marker for predicting EPS in patients undergoing PD using neutral-pH dialysate.

Endometriosis-Associated Infertility: The Role of Biomarkers of Apoptosis and Proliferation in Early Noninvasive Diagnosis

INTRODUCTION: Endometriosis is a common disease that affects up to 15% of women in the reproductive period and leads to infertility in 25%–50% of cases. The diagnosis of endometriosis is delayed for years due to blurred and diverse clinical presentation, therefore, search for a noninvasive biomarker of endometriosis is an important problem of modern medicine. AIM: To study the significance of changes in the profile of biomarkers: regulator of Wnt/β-catenin signaling pathway (axis inhibition protein 1; AXIN-1), soluble cytokeratin 19 fragment (cytokeratin fragment antigen 21-1; CYFRA-21-1), cancer antigen 125 (carbohydrate antigen 125; CA-125) in blood plasma of patients with endometriosis-associated infertility (before surgery and in the postoperative period). MATERIALS AND METHODS: The study included two groups of female patients. The first group consisted of 20 patients of reproductive age with cystic ovarian endometriosis and infertility. All the patients underwent surgical intervention using a laparoscope and a video system, in all the patients the diagnosis of endometriosis was confirmed histologically. Three times in specified periods (before surgery, on the 10th day of the postoperative period, at 6 months), patients with cystic ovarian endometriosis and infertility were taken biomaterial (blood) with further determination of AXIN-1, CYFRA-21-1, CA-125 in blood plasma. The second group consisted of patients of reproductive age with no gynecological pathology. In the second group, biological material (blood) was taken once with further determination of AXIN-1, CYFRA-21-1, CA-125 in blood plasma. RESULTS: Based on the analysis of the measurement data and comparison of their levels, it was found that the content of the studied AXIN-1, СA-125 biomarkers in patients with cystic ovarian endometriosis and infertility was higher than in patients without gynecological pathology (p 0.05). As for CYFRA-21-1 biomarker, initially lower values were noted compared to the control group (p 0.05), however, in the postoperative period, the content of CYFRA-21-1 increased and reached values close to those of healthy patients. CONCLUSION: Determining the levels of AXIN-1, CYFRA-21-1 apoptosis biomarkers and CA-125 proliferation biomarker in blood of patients with endometriosis-associated infertility gives an insight into the pathophysiological processes in the endometrioid ovarian cysts and may be helpful in development of new noninvasive diagnostic methods and target treatment methods.

B-143 Using Big Data Analytics to Measure the Multi-year Consistency of Sigma Metrics for Vitros Oncology Assays

Abstract Background Sigma metrics assess lab quality by incorporating precision, accuracy and total error allowed (TEa). Sigma metrics report quality on a 0-6 scale, with 6 representing World-Class quality. Due to logistical constraints, Sigma metrics are often calculated with limitations such as a small number of analyzers, single reagent lot or short duration. QuidelOrtho developed a novel approach using big data analytics for the objective, automated calculation of Sigma metrics across thousands of Vitros analyzers running in real lab conditions. This approach was previously used to report the Sigma metric performance for 115 assays using data from 2022. Of particular interest is the consistency of quality levels for Vitros oncology assays assessed in the study. The aim of this analysis was to examine Sigma metrics for Vitros oncology assays and compare Sigma metrics to data from 2022. Methods The methods follow the previous approach using the same Python algorithm to extract worldwide QC data from Jan. to Nov. 2023 (inclusive). A QC fluid lot from the study period was selected for each analyte to align with the fluid level reported in the 2022 study, which was based on medical relevance. Metrics were calculated for each set of QC data that originated from a single analyzer, reagent lot and calibration curve; the median Sigma metric is reported in the Results. Proficiency testing limits were utilized as TEa limits where available, with preference to CLIA 2024 limits. Results The following assays reported Sigma metrics as &amp;gt;6 using both 2022 and 2023 data: alpha-fetoprotein, cancer antigen 125, carcinoembryonic antigen, prostate-specific antigen (PSA), free PSA, IgA, and IgG. Assays with higher metrics using 2023 data: cancer antigen 19-9 (5.0 vs &amp;gt;6) and IgM (5.3 vs &amp;gt;6). Assays with lower metrics using 2023 data: cancer antigen 15-3 (4.8 vs 4.4). Conclusions Vitros oncology assays report similar performance for 2022 and 2023. All Vitros oncology assays assessed report Sigma metrics of 4 or greater, indicating they achieve results within the corresponding allowable error.

B-309 Evaluation of the Analytical Performance of Breast and Ovarian Cancer Antigen Assays on the Atellica CI Analyzer

Abstract Background The Atellica® CI Analyzer is an automated, high-throughput integrated chemistry and immunoassay analyzer utilizing both Atellica® CH and Atellica® IM Assays. This study evaluated the analytical performance of the Atellica IM breast cancer antigen CA 15-3™ (CA 15-3) and the ovarian cancer antigen CA 125II™ (CA 125II) Assays on the Atellica CI Analyzer. Methods Precision studies were performed according to CLSI EP05-A3 using native and contrived human serum samples as well as contrived horse serum samples for CA 15-3. One aliquot of each sample pool was tested in duplicate in two runs per day ≥2 hours apart on each analyzer for ≥20 days. Precision studies were evaluated with one reagent lot on two systems. Method comparison studies were performed using three reagent lots according to CLSI EP09c. Individual native and contrived human serum samples were analyzed using the Atellica IM CA 15-3 and CA 125II Assays on the Atellica IM Analyzer and the Atellica CI Analyzer. LoB, LoD, and LoQ were determined as described in CLSI EP17-A2. Results Representative precision and method comparison results for each assay are listed in the table. For the two assays tested, repeatability and within-lab %CVs were &amp;lt;2.4% and &amp;lt;6.9%, respectively. Slopes determined by the weighted Deming linear regression model were approximately 1. Detection capability for the Atellica IM CA 15-3 Assay on the Atellica CI Analyzer was estimated to be 1.0 U/mL, 2.0 U/mL and 3.0 U/mL for LoB, LoD, and LoQ, respectively. When using the Atellica IM CA 125II Assay, detection capability was estimated to be 2.0 U/mL, 3.0 U/mL and 3.0 U/mL for LoB, LoD, and LoQ, respectively. Conclusions Evaluation of the Atellica IM CA 15-3 and CA 125II Assays using the Atellica CI Analyzer demonstrated good precision and equivalent performance compared to the same assays on the Atellica IM Analyzer.