NCT03762590Active, not recruiting
GENetic Education Risk Assessment and TEsting Study
GENetic Education Risk Assessment and TEsting Study (GENERATE)
Source: ClinicalTrials.gov · Last updated 1 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 1000 (estimated)
- First submitted
- 29 Nov 2018
- Start date
- 8 May 2019
- Primary completion date
- 12 Dec 2022
- Lead sponsor
- Dana-Farber Cancer Institute
- Diseases
- Pancreatic cancer
- NCT number
- NCT03762590
What you commit to
- Study type: Interventional
- Planned participants: 1000
- From 8 May 2019 to the primary completion date, 12 Dec 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- Individual with a known cancer susceptibility gene
- Individual who is unable to sign the informed consent because of mental incompetency or psychiatric illness
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.