Pancreatic Cancer Detection Consortium (PCDC) Prospective Cohorts

NCT06271291 | Recruiting

• 4 other identifiers: 23-000161NCI-2024-00504U01CA210138U24CA274496
• Study Type: observational
• Target: 30,000
• Locations: 1 country
• Sites: 7

Brief Summary

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

Pancreatic Carcinoma

Outcome Measures

Primary Outcomes (2)

• Develop a biobank of biospecimens and data of subjects without pancreatic cancer who are at high risk for pancreatic cancer

  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.

  Baseline (at enrollment)

• Follow subjects longitudinally and collect biospecimens and follow-up data and record medical outcomes

  Participants will be followed until study completion, defined as when one or more of the following occur: * Subject has provided a pre-treatment biospecimen after diagnosis with pancreatic ductal adenocarcinoma (PDAC) or it has been determined that collection of a pre-treatment biospecimen sample after PDAC diagnosis is infeasible. * Enrollment cyst determined to not be mucinous and thus not worthy of ongoing surveillance. * Subject has had a complete pancreatectomy. * Subject has died. * Study funding has ended

  Up to study completion, as defined in description

Study Arms (1)

Observational

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.

Other: Non-Interventional Study

Interventions

Non-Interventional Study OTHER

Non-interventional study

Observational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with pancreatic ductal adenocarcinoma (PDAC) family history, PDAC related genetic mutations or high risk or worrisome pancreatic cysts

You may qualify if:

• PDAC FAMILY HISTORY OR PDAC RELATED GENETIC MUTATIONS:
• Age: 50 or older, plus at least one of the following:
• Mutation unknown or absent:
• + 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:
• 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

You may not qualify if:

• 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 English

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• Mayo Clinic: lead

Study Sites (7)

HonorHealth Research Institute

Scottsdale, Arizona, 85258, United States

WITHDRAWN

Piedmont Healthcare

Atlanta, Georgia, 30309, United States

RECRUITING

OSF Saint Francis Medical Center

Peoria, Illinois, 61615, United States

RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68198-6805, United States

RECRUITING

Oregon Health & Science University

Portland, Oregon, 97201, United States

RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

Biospecimens of subjects without pancreatic cancer who are at high-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. Biospecimens will remain available for research beyond the end of study funding.

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Ann L. Oberg, PhD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 21, 2024
• Study Start: December 12, 2024
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

US (7)