Status:
ACTIVE_NOT_RECRUITING
GENetic Education Risk Assessment and TEsting Study
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Mayo Clinic
M.D. Anderson Cancer Center
Conditions:
Candidates for Hereditary Pancreatic Cancer Testing
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of the GENERATE Study is to improve genetic testing and cancer prevention in family members of pancreatic cancer patients who may have genetic mutations (inherited changes). The study will me...
Detailed Description
Around 1 in 10 (10%) pancreatic cancer patients carries an inherited change (mutation) in a gene which can increase the risk of cancer. Relatives of patients with pancreatic cancer are often unaware t...
Eligibility Criteria
Inclusion
- Individual who is 18 years or older
- Individual who has signed the informed consent
- Individual with:
- -A first-degree relative who has (or had) pancreatic ductal adenocarcinoma (PDAC) OR a second-degree relative who has (or had) PDAC and has a known germline mutation in APC, ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2, PMS2, STK11, or TP53
- The germline mutation and history of PDAC must be on the maternal side or paternal side of the individual's family
- Individual with a valid United States mailing address
- Individual with access to a healthcare provider and is willing to share genetic test results with that provider/the study team
Exclusion
- Individual with a known cancer susceptibility gene
- Individual who has received genetic counseling for cancer risk within the last 3 years
- 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 unwilling to complete baseline and follow-up questionnaires
- Individual who has a life expectancy of less than 1 year
- Individual with only APC I1307K mutation within their family
- Individual with only PMS2 exons 12-15 deletion mutation within their family
Key Trial Info
Start Date :
May 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT03762590
Start Date
May 8 2019
End Date
December 31 2027
Last Update
November 10 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215