Clinical trial · Observational
Pancreatic Cancer Early Detection Program
Observational Study to Analyze the Outcomes of Subjects Who - Based Upon Their Sufficiently Elevated Risk for the Development of Pancreatic Adenocarcinoma- Elect to Undergo Early Detection Testing
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Early detection testing is recommended for individuals at elevated risk for the development of Pancreatic Cancer. This Protocol will define sufficiently elevated risk as either equal to or greater than five times the general population risk, or five times the average risk (1.5%) of developing pancreatic cancer by age 70; that is a 7.5% lifetime risk. Our inclusion criteria has a strong focus on the risk for pancreatic cancer imparted by the presence of hereditary cancer genes, as well as by family history. Enrolled subjects will undergo Endoscopic Ultrasound (EUS) alternating with Magnetic Resonance Imaging (MRI), every six to 12 months, for up to 5 years.
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BRCA 1/2 | — | UNRESOLVED | — |
| Familial Atypical Multiple Mole Melanoma | — | UNRESOLVED | — |
| Familial Pancreatic Cancer | — | UNRESOLVED | — |
| FAMMM | — | UNRESOLVED | — |
| Hereditary Pancreatitis | — | UNRESOLVED | — |
| HNPCC | — | UNRESOLVED | — |
| Lynch Syndrome | — | UNRESOLVED | — |
| Pancreas Cancer | Pancreatic Carcinoma | ALIAS | 0.90 |
| Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | ONTOLOGY_EXACT |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic Ultrasound | Procedure | — | UNRESOLVED |
| Magnetic Resonance Imaging (MRI) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Individuals at elevated risk for pancreatic cancer
- description
- Individuals with an elevated risk of developing pancreatic cancer as either equal to or greater than five times the general population risk, or five times the average risk (1.5%) of developing pancreatic cancer by age 70; that is a 7.5% lifetime risk.
- interventionNames
- Procedure: Endoscopic Ultrasound
- Procedure: Magnetic Resonance Imaging (MRI)
Primary outcomes (1)
- measure
- Premalignant or malignant pancreatic conditions found with alternating EUS and MRI testing.
- timeFrame
- 5 years
- description
- Number of Participants with Premalignant or Malignant Pancreatic Conditions, as a Measure of Safety and Efficacy
Secondary outcomes (3)
- measure
- Clinical outcomes which occur as a result of this Protocol
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Any of the following: 1. Known carrier of either the BRCA2 or CDKN2A mutation; 2. Known carrier of any of the following mutations (BRCA1, MLH1, MSH2, PMS2, MSH6, EPCAM , P53, PALB2, APC, or ATM) PLUS first or second degree relative affected with pancreatic cancer; 3. Individual with Peutz-Jeghers Syndrome; 4. Familial Pancreatic Cancer, defined as at least two affected relatives with Pancreatic Cancer, who are first degree relatives with each other, and at least one of those affected must be first degree relative to the study subject; 5. Both parents affected, any age: 6. Any first degree relative diagnosed with pancreatic cancer under age 50; 7. Chronic Pancreatitis Syndrome, defined by either PRSS1 or SPINK1 mutations AND appropriate clinical and family history Exclusion Criteria: 1. Any medical condition that contraindicates endoscopy or biopsy 2. Any medical condition that contraindicates MRI 3. Status post partial or complete resection of the pancreas 4. History of pancreatic cancer, either endocrine or exocrine 5. Clinical suspicion of pancreatic cancer, or any previous radiographic or histologic diagnosis of a pre-malignant finding, including IPMN (Intraductal papillary mucinous neoplasm) and PanIN (Pancreatic intraepithelial Neoplasm). 6. diagnosis of dementia 7. Uncontrolled, current illness 8. Renal insufficiency with serum creatinine greater than 2.0 mg/dl
References
Publications (1)
- DERIVEDRaff JP, Cook B, Jafri FN, Boxer N, Maldonado J, Hopkins U, Roayaie S, Noyer C. Successful Pancreatic Cancer Screening Among Individuals at Elevated Risk Using Endoscopic Ultrasound and Magnetic Resonance Imaging: A Community Hospital Experience. Pancreas. 2022 Nov-Dec 01;51(10):1345-1351. doi: 10.1097/MPA.0000000000002182. PMID 37099777