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Active Not Recruiting
NCT04247503
Cohort Study of Pancreatic Cancer Risk
Conditions: Familial Pancreatic Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Enrollment: 419
Sponsor: Mayo Clinic
Location: Mayo Clinic Rochester Minnesota
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.
Eligibility Criteria
Inclusion Criteria:
1. An individual who has previously consented to the Biospecimen Resource for Pancreas Research (Substudy #2 Family Studies) - IRB 355-06
2. Individual who does not have a personal history of pancreatic cancer and meets one of the following:
1. 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.
OR
2. 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.
OR
3. 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.
OR
4. 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.
3. Age
1. 50 or older, OR
2. Or within 10 years of the age of diagnosis of the youngest PDAC blood relative.
4. Individual with a valid United States mailing address. -
Exclusion Criteria:
1. Individual who has a personal history of PDAC
2. 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).
3. Individual who is unable to sign the informed consent because of mental incompetency or psychiatric illness
4. Individual who is non-English speaking
5. Individual who is a prison inmate -
Source: ClinicalTrials.gov (NCT04247503). StuddyBuddy aggregates publicly available trial information.