A PAncreatic cancer screening study in individuals with New-onset or DeteriOrating diabetes MEllitus (PANDOME study).

Abstract

TPS10607 Background: Pancreatic adenocarcinoma (PC) has a persistently high mortality as it presents in the advanced stages and has largely not benefited from the genomic and immunotherapeutic revolutions in oncology. Improvements in screening to detect early stage cancers are therefore urgently needed. Screening studies such as those from the International CAPS Consortium have demonstrated improved survivals in hereditary high risk individuals. In the sporadic population, individuals with new-onset diabetes (NOD) or long-standing deteriorating diabetes (DD) are at substantially increased risk of PC in the 12 months following these diagnoses and have been proposed as target populations for screening efforts. This trial will study the benefits of PC screening in the latter populations in a community setting. Methods: Individuals ≥ 50 years of age with either NOD or DD will be eligible. Criteria for NOD (within the past 12 months) include: fasting blood glucose ≥ 126 mg/dL, random blood glucose ≥ 200 mg/dL, or HbA1c ≥ 6.5%, with confirmed prior normal values. For those without prior glycemic values, a HbA1c ≥ 7.0% is required. Transition from pre-diabetes requires an increase in HgA1c of ≥ 0.5%. DD is defined by an increase in HbA1c of ≥ 2% within the past six months that is not associated with medication non-compliance or weight gain. Study participants will undergo every 6 months: evaluation by an APRN, testing for anxiety and depression and blood donation for biobanking purposes. High resolution MRI/MRCP with gadolinium will be performed at study entry and annually for 2 years. Images will be reviewed at a multi-disciplinary tumor board consisting of body-image certified radiologists, interventional gastroenterologists, hepatobiliary surgeons and medical oncologists. MRI results will be classified according to a novel PANC-RADS system. High-risk pancreatic findings will be further interrogated by endoscopic ultrasound (EUS). Study endpoints include detection rate of high-risk lesions, referrals for EUS and surgery and detection of incidental findings leading to unnecessary procedures. Adverse psychological impacts will be assessed through HADS testing. Target accrual: 500 patients within 3 years. Clinical trial information: NCT03937453 .