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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04254133.
Locations matching your search criteria
United States
Washington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer ConsortiumStatus: Enrolling By Invitation
Contact: Burcu F. Darst
Phone: 206-667-1036
PRIMARY OBJECTIVES:
I. Determine clinical, pathologic, and molecular predictors of germline alterations in deoxyribonucleic acid (DNA) repair genes (gDRG) mutation carriers in a population-based cohort of men diagnosed with prostate cancer (PC).
II. Characterize stepwise cascade genetic testing for at-risk male relatives of PC cases with gDRG mutations.
III. Evaluate the association between genetic and molecular factors with clinical features of PC and disease aggressiveness, including disease progression.
IV. Identify a cohort of unaffected men with gDRG mutations who may benefit from an early detection protocol for high-risk men.
V. Evaluate effectiveness of a germline genetic testing education video to increase participation in genetic testing among PC patients.
OUTLINE: This is an observational study.
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. Patients 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.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationFred Hutch/University of Washington/Seattle Children's Cancer Consortium
Principal InvestigatorHeather H. Cheng
