NCT04254133

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

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 1,360 (estimated)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: Male
• Age: 35 Years – 89 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Prostate Carcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-11-30
• Primary completion: 2028-08-31
• Completion: 2028-08-31
• First posted: 2020-02-05
• Last updated: 2026-01-30

Locations

1 site across 1 country: United States