Clinical trial · Interventional
EpiDetect Study: Clinical Validation of a Pancreatic Cancer Detection Test in New-Onset Diabetes Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study not initiated.
Summary
Brief summary (as posted)
Bluestar Genomics has developed a non-invasive test that aids in the qualitative detection of occult pancreatic cancer in patients with new onset type II diabetes (NOD) who are 50 years old or older. The purpose of this study is to validate the performance of Bluestar Genomics early-detection pancreatic cancer test. The study is prospective, longitudinal and interventional; tests will be ordered and results returned to site-investigators. If the assay returns a pancreatic cancer signal "detected" result, the study participant will undergo MRI imaging to evaluate for the presence of pancreatic cancer. The study is planned to enroll 10,000 newly diagnosed type II diabetic subjects according to inclusion and exclusion criteria.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Early detection pancreatic cancer test | Device | — | UNRESOLVED |
| Early detection pancreatic cancer test and MRI Imaging | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- EpiDetect Arm
- description
- 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.
- interventionNames
- Device: Early detection pancreatic cancer test
- type
- EXPERIMENTAL
- label
- EpiDetect "not detected" MRI Arm
- description
- 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.
- interventionNames
- Device: Early detection pancreatic cancer test and MRI Imaging
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available