Genetic Information to Inform Treatment and Screening for Prostate Cancer, GIFTS Study
NCT ID: NCT04254133
Last Updated: 2025-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
1360 participants
OBSERVATIONAL
2018-11-30
2028-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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Case Ascertainment
Men with prostate cancer
Questionnaire
Complete questionnaire
Biospecimen Collection
Provide saliva samples
Genetic Testing
Undergo genetic testing
Genetic Counseling
Undergo counseling
Laboratory Biomarker Analysis
Correlative Studies
Family Recruitment
Male relatives of men with prostate cancer
Questionnaire
Complete questionnaire
Biospecimen Collection
Provide saliva samples
Genetic Testing
Undergo genetic testing
Genetic Counseling
Undergo counseling
Laboratory Biomarker Analysis
Correlative Studies
Interventions
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Questionnaire
Complete questionnaire
Biospecimen Collection
Provide saliva samples
Genetic Testing
Undergo genetic testing
Genetic Counseling
Undergo counseling
Laboratory Biomarker Analysis
Correlative Studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* Prior bone marrow transplant
* Currently under treatment for a hematologic malignancy
* Study team members
* Unable to provide informed consent, e.g. decisional impairment
* Prior bone marrow transplant
* Currently under treatment for a hematologic malignancy
* Study team members
35 Years
89 Years
MALE
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Fred Hutchinson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Burcu Darst
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Heather H Cheng
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Daniel W Lin
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Colin C Pritchard
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
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Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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Other Identifiers
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NCI-2020-00933
Identifier Type: REGISTRY
Identifier Source: secondary_id
8754
Identifier Type: OTHER
Identifier Source: secondary_id
RG1004177
Identifier Type: -
Identifier Source: org_study_id
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