EpiDetect Study: Clinical Validation of a Pancreatic Cancer Detection Test in New-Onset Diabetes Patients
Pancreatic Cancer
About this trial
This is an interventional screening trial for Pancreatic Cancer focused on measuring Pancreatic cancer; Early pancreatic cancer detection
Eligibility Criteria
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 (<1 week) of the qualifying DM blood test (allowed exception: nasal, topical, oral budesonide)
- Any surgery requiring general anesthesia within 2 months of collection
- Local anesthetic (including dental novocaine) within 1 week of collection
- History or presence of HIV/AIDs, Hepatitis A or E within the past five years, TB, any kind of prion disorder (e.g., CJD)
- Blood transfusion within 1 month
- Organ transplant recipient
- Currently pregnant, or pregnancy within last 12 months
- Receipt of systemic immunomodulation therapy within past 12 months
- Significant medical condition that in the site investigator's opinion would compromise the subject's ability to tolerate study interventions
Sites / Locations
- Bluestar Genomics, Inc.
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
EpiDetect Arm
EpiDetect "not detected" MRI Arm
Each subject can undergo to up to 3 blood draws; at the time of enrollment (T0), at 6 months (T1) and 12 months (T2) from diabetes diagnosis. After 24 months from diabetes diagnosis, a review of the electronic medical records (EMR) will be performed for all subjects with a "not detected" test result.
A pre-specified number of cases with test results "not detected" will be randomly selected, gender ratio and age matched to subjects with test results "detected" and will undergo MRI imaging at T0 (n=226), at T1 (n=208 ) at T2 (n=208 ) and 24 months (n=208) from diabetes diagnosis.