Genetic Information to Inform Treatment and Screening for Prostate Cancer, GIFTS Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Questionnaire, Biospecimen Collection, Genetic Testing, Genetic Counseling.
- Who it may be relevant to
- Registry conditions: Prostate Carcinoma. Basic parameters: 35 years — 89 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Genetic Information to Inform Treatment and Screening (GIFTS) Study for Prostate Cancer
Overview
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 may also receive an educational flyer with or without a educational video regarding prostate cancer and genetic testing.
Participants will be sent newsletters every year to encourage study engagement and update health questionnaires every two years.
Interventions
- Behavioral Questionnaire
Complete questionnaire - Procedure Biospecimen Collection
Provide saliva samples - Diagnostic test Genetic Testing
Undergo genetic testing - Other Genetic Counseling
Undergo counseling - Other Laboratory Biomarker Analysis
Correlative Studies
Primary outcome measures
- Identification of a population-based cohort of men with prostate cancer (PC) and germline deoxyribonucleic acid (DNA) repair gene (gDRG) mutations [Time frame: From the start of study through death (up to 20 years)]
- Clinical, pathologic, and molecular predictors of gDRG mutation carriers for men with PC [Time frame: From the start of study through death (up to 20 years)]
- Utility and feasibility of cascade genetic testing through use of family history of men with PC identified to have gDRG mutations [Time frame: From the start of study through death (up to 20 years)]
- Identification of a cohort of men with gDRG mutations without PC [Time frame: From the start of study through death (up to 20 years)]
- Effectiveness of a germline genetic testing education video: Number of participants who participate in genetic testing after watching germline genetic testing video [Time frame: Up to 6 months]
Eligibility criteria
Inclusion Criteria: Case Ascertainment \[Cancer Surveillance System (CSS)/Washington State Cancer Registry (WSCR)\]:
- Signed informed consent form providing agreement for germline genetic and molecular testing, use release of health and research information; and
- Male aged 35 to 89 years; and
- Diagnosis of prostate cancer; and
- Resident of Washington state at diagnosis; and
- Willing to complete a questionnaire (online or on paper) to provide basic demographic information, family cancer history, and health history; and
- Willing and able to provide a saliva sample; and
- United States (U.S.) mailing address.
Inclusion Criteria: Case Ascertainment \[UW Medical Center (UWMC)/UW Harborview Medical Center (UWHMC)\]:
- Signed informed consent form providing agreement for germline genetic and molecular testing, use release of health and research information; and
- Male aged 35 to 89 years; and
- Diagnosis of prostate cancer; and
- Self-identifies as Black, African American, or African; and
- Receiving care at UWMC or UWHMC; and
- Willing and able to provide a saliva sample; and
- Able to provide either a U.S. mailing address or Email address or Phone number.
Inclusion Criteria: Family Recruitment
- Signed informed consent form providing agreement for germline genetic and molecular testing, use and release of health and research information; and
- Males aged 35 to 89 years; and
- Willingness to complete a questionnaire (online or on paper) to provide basic demographic information, family cancer history, and health history; and
- Willing and able to provide a saliva sample; and
- U.S. mailing address
Exclusion Criteria: 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- Fred Hutch/University of Washington Cancer Consortium — Seattle
Identifiers
NCT: NCT04254133 · RG1004177 · P50CA097186 · NCI-2020-00933 · 8754