EpiDetect Study: Clinical Validation of a Pancreatic Cancer Detection Test in New-Onset Diabetes Patients

Inclusion Criteria: * ≥50 years of age or older at the time of enrollment * Willing to provide and sign the informed consent form * Must have 2 occurrences from among the below parameters of diabetes mellitus (PDMs) in past 90 days measured in outpatient setting (not in urgent care, emergency room or while inpatient): * FBG ≥126mg/dl * HbA1c ≥ 6.5% * RBG ≥200mg/dl * 2-hour post-glucose ≥ 200mg/dl (OGTT) * Must have had glycemic parameter measured in 3-18 months prior to screening without meeting DM criteria * Must be willing to provide several tubes of blood without endangering health * No history of pancreatic cancer * No history of IPMNs, other neoplastic cysts and pancreatitis * No active cancers within the past 5 years (with the exception of non-melanoma skin cancers resolved/treated \> 1 year prior to enrollment and in situ carcinomas) Exclusion Criteria: * Prior DM diagnosis * Met criteria for DM ≥91 days prior to enrollment (patients with prior gestational diabetes that has resolved are NOT acceptable to enroll) * Carried a DM diagnosis or used anti-DM medications at a time greater than or equal to 91 days prior to enrollment * Any known pancreatic lesions * Received cancer treatment within the past 5 years (with the exception of treatment of non- melanoma skin cancer), carrying a current cancer diagnosis, and/or being investigated for suspicion of past cancer recurrence. * Current chronic or acute oral steroid use * History of intra-articular steroid injections (\<…