GENetic Education Risk Assessment and TEsting Study

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 measure how different methods of genetic education increase the rate of genetic testing in these families. This is an investigational study to measure the effects of two methods of genetic education. Participants may elect to undergo genetic testing as part of the study and will be asked to provide a saliva sample via a saliva-testing kit. The genetic testing done in this study is FDA approved and will be processed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory. Up to 1,000 participants will be enrolled in this study.

Sex

All

Minimum age

18 Years

Inclusion Criteria:

* 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 Criteria:

* 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

• DERIVEDRodriguez NJ, Furniss CS, Yurgelun MB, Ukaegbu C, Constantinou PE, Fortes I, Caruso A, Schwartz AN, Stopfer JE, Underhill-Blazey M, Kenner B, Nelson SH, Okumura S, Zhou AY, Coffin TB, Uno H, Horiguchi M, Ocean AJ, McAllister F, Lowy AM, Klein AP, Madlensky L, Petersen GM, Garber JE, Lippman SM, Goggins MG, Maitra A, Syngal S. A Randomized Trial of Two Remote Health Care Delivery Models on the Uptake of Genetic Testing and Impact on Patient-Reported Psychological Outcomes in Families With Pancreatic Cancer: The Genetic Education, Risk Assessment, and Testing (GENERATE) Study. Gastroenterology. 2024 May;166(5):872-885.e2. doi: 10.1053/j.gastro.2024.01.042. Epub 2024 Feb 5. PMID 38320723