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ENROLLING BY INVITATION

NCT04254133

Genetic Information to Inform Treatment and Screening for Prostate Cancer, GIFTS Study

Sponsor: Fred Hutchinson Cancer Center

View on ClinicalTrials.gov

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.

Official title: Genetic Information to Inform Treatment and Screening (GIFTS) Study for Prostate Cancer

Key Details

Gender

MALE

Age Range

35 Years - 89 Years

Study Type

OBSERVATIONAL

Enrollment

1360

Start Date

2018-11-30

Completion Date

2028-08-31

Last Updated

2026-01-30

Healthy Volunteers

Yes

Conditions

Prostate Carcinoma

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

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

Locations (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States