Cohort Study of Pancreatic Cancer Risk

NCT04247503 | Active Not Recruiting

• 3 other identifiers: 19-010791U01CA210138NCI-2023-05521
• Study Type: observational
• Target: 419
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to develop a cohort of individuals without pancreatic cancer, but who are at increased risk of developing it due to family history or genetic predisposition. These high-risk individuals will be asked to provide baseline and annual (serial) follow-up blood samples for the duration of the study funding. \[Blood collection was discontinued August 2025.\] Mayo Clinic is part of a national Pancreatic Cancer Detection Consortium (PCDC) which aims to establish a high-risk cohort with the goal of validating blood biomarkers (discovered/developed outside of this protocol) using the samples collected serially (annually) that predict or detect pancreatic cancer prior to clinical diagnosis.

Conditions

Familial Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of cancer in the risk cohort

  Enumeration of number of new cases of pancreatic cancer and other cancers that incidentally develop from baseline enrollment among those who enroll in the cohort. This number will be a numerator for a risk ratio. The denominator will be person years at risk starting from age 50.

  Through study completion, an average of 5 years.

Secondary Outcomes (2)

• Association of baseline patient characteristics with incident cancers

  through study completion an average of 5 years.

• Measurement of test accuracy of biomarkers to detect pancreatic cancer

  Through study completion, an average of 5 years.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals aged 50 and older without pancreatic cancer who are members of kindreds containing three blood relatives with pancreatic cancer, OR who carry a mutation in a known predisposition gene for pancreatic cancer.

You may qualify if:

• An individual who has previously consented to the Biospecimen Resource for Pancreas Research (Substudy #2 Family Studies) - IRB 355-06
• Individual who does not have a personal history of pancreatic cancer and meets one of the following:
• Has relatives in family that contains pancreatic cancer, and carries a known germline mutation in APC, ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2, PMS2, STK11, or TP53.
• Is a first- or second-degree blood relative of an individual with a diagnosis of pancreatic ductal adenocarcinoma (PDAC) and this PDAC patient has a germline mutation in APC, ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2, PMS2, STK11, or TP53.
• Is a first- or second-degree blood relative of an individual with a germline mutation in one of these genes and where the mutation carrier is also a first-degree relative to a PDAC case.
• Is a blood relative to a PDAC patient in a family that contains three blood relatives (all maternal side or all paternal side) with PDAC.
• Age
• or older, OR
• Or within 10 years of the age of diagnosis of the youngest PDAC blood relative.
• Individual with a valid United States mailing address. -

You may not qualify if:

• Individual who has a personal history of PDAC
• Individual who has received a bone marrow transplant, who has had a blood transfusion within the last 7 days, or who has an active hematologic malignancy (i.e., leukemia or lymphoma).
• Individual who is unable to sign the informed consent because of mental incompetency or psychiatric illness
• Individual who is non-English speaking
• Individual who is a prison inmate -

Sponsors & Collaborators

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

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITHOUT DNA

50 cc of blood annually for 5 years. \[Blood was collection discontinued August 2025.\]

MeSH Terms

Conditions

Pancreatic carcinoma, familial

Study Officials

• Shounak Majumder, M.D.

  The Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: January 30, 2020
• Study Start: December 11, 2019
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

US (1)