Clinical trial · Observational
Pancreatic Cancer Detection Consortium (PCDC) Prospective Cohorts
NCT06271291CI-TRIAL-00125511recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
This study evaluates individuals without pancreatic cancer, but who have been determined to be at higher-than-average lifetime risk of developing pancreatic cancer to help detect pancreatic cancer or other cancers at an earlier time when they might be more easily treated and cured.
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 Carcinoma | Pancreatic Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-Interventional Study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational
- description
- Participants undergo blood sample collection, complete questionnaires, have their medical records reviewed and undergo pancreatic cyst fluid collection during standard of care endoscopic ultrasounds fine needle aspiration.
- interventionNames
- Other: Non-Interventional Study
Primary outcomes (2)
- measure
- Develop a biobank of biospecimens and data of subjects without pancreatic cancer who are at high risk for pancreatic cancer
- timeFrame
- Baseline (at enrollment)
- description
- Assessed by the number of specimens collected for subjects at right risk for pancreatic cancer due to a strong family history, a mutation in a known pancreatic cancer predisposition gene, or Fukuoka worrisome or high-risk pancreatic cysts.
- measure
- Follow subjects longitudinally and collect biospecimens and follow-up data and record medical outcomes
- timeFrame
- Up to study completion, as defined in description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* PDAC FAMILY HISTORY OR PDAC RELATED GENETIC MUTATIONS:
* Age: 50 or older, plus at least one of the following:
* Mutation unknown or absent:
* 2+ relatives with PDAC on same side of family where 2 affected are first degree related to each other and at least 1 affected is first degree related to subject;
* OR 2+ affected first degree relatives \[(FDR), defined as blood related parents, siblings, or children\]
* Known pathogenic/likely pathogenic (P/LP) mutation in at least one of the following:
* CDKN2A/p16, Peutz-Jeghers syndrome (PJS) serine/threonine kinase 11 (STK11), Hereditary pancreatitis with confirmed protease serine 1 (PRSS1)
* OR 1+ or second degree relative (SDR) with PDAC and a known P/LP mutation in one or more of:
* ATM, BRCA1, BRCA2, PALB2, Lynch syndrome (MLH1, MSH2, MSH6, PMS2, EPCAM), TP53
* HIGH-RISK OR WORRISOME PANCREATIC CYSTS:
* 18 years of age or greater and meeting Fukuoka worrisome (FW) or Fukuoka high-risk (FHR) criteria
* High risk stigmata:
* Obstructive Jaundice in a patient with cystic lesion of the head of the pancreas
* Enhancing mural nodule ≥ 5 mm
* Main pancreatic duct ≥ 10 mm
* Worrisome features:
* Presence of pancreatic duct stricture, defined as focal pancreatic duct narrowing with upstream duct =\> 6 mm
* Cyst ≥ 3 cm
* Enhancing mural nodule \< 5 mm
* Thickened/Enhancing cyst wall
* Main duct size 5-9 mm
* Pancreatitis
* Lymphadenopathy
* Increased CA 19-9
* Cyst growth rate ≥ 5 mm /2 years
Exclusion Criteria:
* Is unable to provide informed consent
* Has received a non-autologous bone marrow transplant or has an active hematologic malignancy (i.e., leukemia or lymphoma)
* Current or prior history of PDAC or total pancreatectomy
* Is currently a prison inmate
* Is not able to speak or read EnglishReferences
Publications (0)
Data not yet available
No reference posted for this study.