Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
NCT Number: NCT04254133
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.
Interested in participating?
Request Info35 year–89 year
Male
Observational
Seattle, Washington, 98109, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Case Ascertainment [Cancer Surveillance System (CSS)/Washington State Cancer Registry (WSCR)]:
Inclusion criteria
Case Ascertainment [UW Medical Center (UWMC)/UW Harborview Medical Center (UWHMC)]:
Inclusion criteria
Family Recruitment
Exclusion criteria
Case Ascertainment
Exclusion criteria
Family Recruitment
Complete questionnaire
Other names: Questionnaires
Provide saliva samples
Other names: Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo genetic testing
Other names: Genetic Analysis, Genetic Examination, Genetic Test
Undergo counseling
Correlative Studies
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 6 months
Will determine whether patients are more likely to participate in germline genetic testing after viewing an education video about prostate cancer genetic testing.
Fred Hutchinson Cancer Center
Other
Genetic Information to Inform Treatment and Screening (GIFTS) Study for Prostate Cancer
Acronym: GIFTS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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