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

Prostate Carcinoma Clinical Trial

— GIFTS  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04254133
• Other study ID #: RG1004177
• Secondary ID: P50CA097186NCI-2
• Status: Enrolling by invitation
• Start date: November 30, 2018
• Est. completion date: August 31, 2028

Study information

• Verified date: February 2024
• Source: Fred Hutchinson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 will be sent newsletters every year to encourage study engagement and update health questionnaires every two years.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1360
• Est. completion date: August 31, 2028
• Est. primary completion date: August 31, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 35 Years to 89 Years

Eligibility

Inclusion Criteria: Case Ascertainment

• Signed informed consent form providing agreement for germline genetic testing, use and release of health and research information

• 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

Inclusion Criteria: Family Recruitment

• 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: 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

Related Conditions & MeSH terms

• Prostate Carcinoma
• Prostatic Neoplasms

Intervention

Behavioral:
• Questionnaire
Complete questionnaire

Procedure:
• Biospecimen Collection
Provide saliva samples

Diagnostic Test:
• Genetic Testing
Undergo genetic testing

Other:
• Genetic Counseling
Undergo counseling
• Laboratory Biomarker Analysis
Correlative Studies

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of a population-based cohort of men with prostate cancer (PC) and germline deoxyribonucleic acid (DNA) repair gene (gDRG) mutations	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.	From the start of study through death (up to 20 years)
Primary	Clinical, pathologic, and molecular predictors of gDRG mutation carriers for men with PC	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.	From the start of study through death (up to 20 years)
Primary	Utility and feasibility of cascade genetic testing through use of family history of men with PC identified to have gDRG mutations	To be determined by collection of information about participants' family history and subsequent analysis of cascade genetic testing outcomes.	From the start of study through death (up to 20 years)
Primary	Identification of a cohort of men with gDRG mutations without PC	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.	From the start of study through death (up to 20 years)