Clinical trial · Interventional
Prospective Screening for Pancreatic Ductal Adenocarcinoma in High-Risk Individuals
NCT06122896CI-TRIAL-00113019recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this research is to see if adding blood-based tests and symptom review to standard-of-care pancreatic cancer screening procedures can identify cancer early among individuals with increased risk.
Conditions
Conditions (5)
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 |
| Pancreatic Ductal Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Pancreatic Neoplasm | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
| PDAC | Pancreatic Ductal Adenocarcinoma | ALIAS | 0.90 |
| PDAC - Pancreatic Ductal Adenocarcinoma | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic Ultrasound | Diagnostic Test | — | UNRESOLVED |
| Magnetic Resonance Cholangiopancreatography | Combination Product | — | UNRESOLVED |
| Magnetic Resonance Imaging | Combination Product | — | UNRESOLVED |
| Screening Blood Tests | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pancreatic Cancer High-Risk Participants
- description
- Study procedures will be conducted as follows: * Baseline visit with questionnaires, blood tests, and pancreas screening procedure (EUS or MRI/MRCP). * Pancreas screening procedures (Endoscopic ultrasound (EUS), or Magnetic Resonance (MRI)/Magnetic Resonance Cholangiopancreatography (MRCP), and collection of blood, stool, and saliva samples) every 12 months. * Blood tests and questionnaires every 6 months. * Follow up visits.
- interventionNames
- Other: Screening Blood Tests
- Diagnostic Test: Endoscopic Ultrasound
- Combination Product: Magnetic Resonance Imaging
- Combination Product: Magnetic Resonance Cholangiopancreatography
Primary outcomes (3)
- measure
- Number of Incident Pancreatic Cancers or High-Grade Pancreatic Neoplasms
- timeFrame
- 6-monthly for 3 years with 5-year follow-up
- description
- Subjects will be counted in this metric if they have pathological tissue confirmation of a pancreatic cancer or high-grade dysplasia during each observation period.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Participants must meet any of the following: * Individuals with pathogenic/likely pathogenic germline variants in STK11, and age ≥30 years. * Individuals with pathogenic/likely pathogenic germline variants in CDKN2A, and age ≥40 years (or 10 years younger than the earliest exocrine pancreatic cancer diagnosis in the family, whichever is earlier). * Individuals with pathogenic/likely pathogenic germline variants in one of the other pancreatic cancer susceptibility genes (ATM, BRCA1, BRCA2, MLH1, MSH2, MSH6, EPCAM, PALB2, TP53), and age ≥50 years (or 10 years younger than the earliest exocrine pancreatic cancer diagnosis in the family, whichever is earlier) AND • Exocrine pancreatic cancer in ≥1 first- or second-degree relative from the same side of (or presumed to be from the same side of) the family as the identified pathogenic/likely pathogenic germline variant. * Individuals with pathogenic/likely pathogenic variants in PRSS1 AND a clinical phenotype consistent with hereditary pancreatitis, and age ≥40 years (or 20 years after onset of pancreatitis, whichever is earlier). * Individuals with familial pancreatic cancer including: * Family history of exocrine pancreatic cancer in ≥2 first-degree relatives from the same side of the family, even in the absence of a known pathogenic/likely pathogenic germline variant, OR * Family history of exocrine pancreatic cancer in 1 affected first-degree relative and 1 second-degree relative, even in the absence of a known pathogenic/likely pathogenic germline variant, OR * Family history of exocrine pancreatic cancer in ≥3 first- and/or second-degree relatives from the same side of the family, even in the absence of a known pathogenic/likely pathogenic germline variant. * Individuals who are undergoing clinically recommended pancreatic cancer surveillance. Exclusion Criteria: * Individuals with active or prior pancreatic ductal adenocarcinoma diagnosis. * Individuals with any active metastatic cancer. * Individuals who are unable to give informed consent. * Individuals who are under the age of 18 (infants, children, teenagers). * Individuals unable to tolerate Magnetic Resonance Imaging/Magnetic Resonance Cholangiopancreatography and Endoscopic Ultrasound. * Pregnant women are unlikely to be undergoing screening procedures and will not be considered eligible but can consent to the study at a later date.
References
Publications (0)
Data not yet available
No reference posted for this study.