Clinical trial · Observational
Genetic Information to Inform Treatment and Screening for Prostate Cancer, GIFTS Study
Genetic Information to Inform Treatment and Screening (GIFTS) Study for Prostate Cancer
NCT04254133CI-TRIAL-00118747GIFTSenrolling by invitationClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Carcinoma | Prostate Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Genetic Counseling | Other | — | UNRESOLVED |
| Genetic Testing | Diagnostic Test | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Questionnaire | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Case Ascertainment
- description
- Men with prostate cancer
- interventionNames
- Behavioral: Questionnaire
- Procedure: Biospecimen Collection
- Diagnostic Test: Genetic Testing
- Other: Genetic Counseling
- Other: Laboratory Biomarker Analysis
- label
- Family Recruitment
- description
- Male relatives of men with prostate cancer
- interventionNames
- Behavioral: Questionnaire
- Procedure: Biospecimen Collection
- Diagnostic Test: Genetic Testing
- Other: Genetic Counseling
- Other: Laboratory Biomarker Analysis
Primary outcomes (5)
- measure
- Identification of a population-based cohort of men with prostate cancer (PC) and germline deoxyribonucleic acid (DNA) repair gene (gDRG) mutations
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 35 Years
- Maximum age
- 89 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.