Genetic Information to Inform Treatment and Screening for Prostate Cancer, GIFTS Study
- Conditions
- Prostate Carcinoma
- Interventions
- Behavioral: QuestionnaireProcedure: Biospecimen CollectionDiagnostic Test: Genetic TestingOther: Genetic CounselingOther: Laboratory Biomarker Analysis
- Registration Number
- NCT04254133
- Lead Sponsor
- Fred Hutchinson Cancer Center
- Brief Summary
This trial studies the role of inherited (present at birth) mutations in cancer risk genes such as BRCA2, BRCA1, ATM, CHEK2, and others in relation to prostate cancer. This study may help researchers understand the frequency and importance of inherited mutations in cancer risk genes in patients with prostate cancer and potentially help identify better ways to treat cancer in patients who have a mutation in one of these genes.
- Detailed Description
OUTLINE:
Participants complete questionnaire over 20 minutes at baseline, then undergo collection of saliva sample for genetic testing. Participants identified to have an inherited mutation in a deoxyribonucleic acid (DNA) repair gene undergo genetic counseling. Participants whose genetic testing does not indicate an inherited mutation in a DNA repair gene receive a letter thanking them for their participation and emphasizing the importance of ongoing communication with their physician and family members about cancer risk.
Participants will be sent newsletters every year to encourage study engagement and update health questionnaires every two years.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- Male
- Target Recruitment
- 1360
Case Ascertainment
- Signed informed consent form providing agreement for germline genetic testing, use and release of health and research information
- Male aged 35 to 89 years
- Diagnosis of prostate cancer
- Resident of Washington state
- Willing to complete a questionnaire (online or on paper) to provide basic demographic information, family cancer history, and health history
- Willing and able to provide a saliva sample
- United States (U.S.) mailing address
Inclusion Criteria: Family Recruitment
- Signed informed consent form providing agreement for germline genetic testing, use and release of health and research information
- Males aged 35 to 89 years
- Willingness to complete a questionnaire (online or on paper) to provide basic demographic information, family cancer history, and health history
- Willingness and ability to provide a saliva sample
- U.S. mailing address
Case Ascertainment
- Unable to provide informed consent, e.g. decisional impairment
- Prior bone marrow transplant
- Currently under treatment for a hematologic malignancy
- Study team members
Exclusion Criteria: Family Recruitment
- Unable to provide informed consent, e.g. decisional impairment
- Prior bone marrow transplant
- Currently under treatment for a hematologic malignancy
- Study team members
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Case Ascertainment Genetic Testing Men with prostate cancer Family Recruitment Laboratory Biomarker Analysis Male relatives of men with prostate cancer Case Ascertainment Biospecimen Collection Men with prostate cancer Family Recruitment Biospecimen Collection Male relatives of men with prostate cancer Case Ascertainment Questionnaire Men with prostate cancer Case Ascertainment Laboratory Biomarker Analysis Men with prostate cancer Family Recruitment Genetic Testing Male relatives of men with prostate cancer Family Recruitment Genetic Counseling Male relatives of men with prostate cancer Case Ascertainment Genetic Counseling Men with prostate cancer Family Recruitment Questionnaire Male relatives of men with prostate cancer
- Primary Outcome Measures
Name Time Method Utility and feasibility of cascade genetic testing through use of family history of men with PC identified to have gDRG mutations From the start of study through death (up to 20 years) To be determined by collection of information about participants' family history and subsequent analysis of cascade genetic testing outcomes.
Identification of a population-based cohort of men with prostate cancer (PC) and germline deoxyribonucleic acid (DNA) repair gene (gDRG) mutations From the start of study through death (up to 20 years) Identification to be determined through the Washington State Cancer Registry and by genetic testing on saliva samples for inherited mutations in cancer risk genes such as BRCA2, BRCA1, ATM, and others in prostate cancer.
Clinical, pathologic, and molecular predictors of gDRG mutation carriers for men with PC From the start of study through death (up to 20 years) Predictors to be identified by analyzing information provided by participants on their health history and potentially further testing or chart review on participants who consent to future contact.
Identification of a cohort of men with gDRG mutations without PC From the start of study through death (up to 20 years) Identification to be determined through family history of men with PC identified through the Washington State Cancer Registry and by genetic testing on saliva samples for inherited mutations in cancer risk genes such as BRCA2, BRCA1, ATM, and others in prostate cancer.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Fred Hutch/University of Washington Cancer Consortium
🇺🇸Seattle, Washington, United States