GENERATE

GENERATE

Clinicaltrials.gov identifier:
NCT03762590

Prevention:
Pancreatic

Study Contact Information:

For any questions about the study, contact us by email or by phone: (617) 582-9444. 


GENetic Education Risk Assessment and TEsting Study (GENERATE)

About the Study

The goal of this research study is to increase the uptake of genetic testing among family members of pancreatic cancer patients who may carry a genetic mutation.

This study involves education about genetic testing, undergoing genetic testing for cancer risk (for those who choose to)and completion of a series of 4 sets of questionnaires.

For more information, visit the study website

Type of Study

This is a two-arm, cluster randomized study.

  • This study has 2 arms, which means that families will be assigned into two different study groups.
  • This is a cluster randomized study, which means that families will be placed into one of the two groups by chance. Neither participants nor the study team will choose the group participants are placed in.

What the Study Entails

Participants who qualify for this study will:

  • Receive education about genetic testing
  • Fill out personal and family health history information
  • Undergo genetic testing (saliva sample) for 30 genes associated with inherited cancer risk (if they choose to do so)
  • Complete a series of questionnaires regarding their cancer risk distress, knowledge of genetic testing, factors in decision making, degree of family communication about genetic test results, uptake of surveillance and experience 

Study Locations

There is no travel required for this study. People can participate from anywhere in the United States as long as they have Internet access. 

This Study is Open To:

You can participate if you:

  • Are 18 years of age or older
  • Have signed the informed consent
  • Have a first or second-degree relative with a diagnosis of pancreatic ductal adenocarcinoma (PDAC) and a germline mutation in APC, ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2, PMS2, STK11, or TP53

OR

  • Have an unaffected first or second-degree relative with a germline mutation in one of these genes who is a first or second degree relative to a PDAC case
  • The germline mutation and history of PDAC must be on the same side of your family
  • Have a valid mailing address in the U.S. 
  • Have access to a healthcare provider and are willing to share genetic test results with that provider/the study team
This Study is Not Open To:

People are excluded if they:

  • Have a known cancer susceptibility gene
  • Have received genetic counseling for cancer risk within the last 3 years
  • Have received a bone marrow transplant, had a blood transfusion wihtin the last 7 days, or have an active hematologic malignancy (i.e. leukemia or lymphoma)
  • Are unable to sign the informed consent because of mental incompetency or psychiatric illness
  • Are unwilling to complete a series of questionnaires for up to 15 months
  • Have a life expectancy of less than 1 year
  • Have APC I1307K as the only inherited mutation within their family
  • Have PMS2 exons 12-15 deletion as the only inherited mutation within their family