Clinical trial · Interventional
New Onset Diabetes Management for Earlier Detection of Pancreatic Cancer (NODMED)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): enrollment targets not met
Summary
Brief summary (as posted)
Bluestar Genomics has developed a non-invasive test that aids in 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 evaluate the performance of Bluestar Genomics early-detection pancreatic cancer test in a clinical setting. The study is prospective, longitudinal and interventional; tests will be ordered and results returned to site-investigators. If the test 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 6,550 newly diagnosed type 2 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI/Imaging | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Pancreatic Cancer Signal Detection = Detected
- description
- Subjects with test results "detected" will undergo MRI/Imaging
- interventionNames
- Other: MRI/Imaging
- type
- NO_INTERVENTION
- label
- Pancreatic Cancer Signal Detection = Not Detected
Primary outcomes (3)
- measure
- Positive Predictive Value (PPV)
- timeFrame
- 12 months or until diagnostic resolution
- description
- defined as the proportion of participants with pancreatic neoplasia diagnosis out of all subjects with pancreatic signal "detected" test result.
- measure
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 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 that did NOT meet DM criteria Must be willing to provide several tubes of blood without endangering health No history of pancreatic cancer or other known pancreatic neoplasia 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 cancers) 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 (aside from diabetes) 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