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

Fred Hutchinson Cancer Center (FHCC)

Status: Invitation-only

Conditions: Prostate Carcinoma

Treatments: Other: Genetic Counseling; Procedure: Biospecimen Collection; Behavioral: Questionnaire; Other: Laboratory Biomarker Analysis; Diagnostic Test: Genetic Testing

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04254133

RG1004177

NCI-2020-00933 (Registry Identifier)

P50CA097186 (U.S. NIH Grant/Contract)

8754 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,360 estimated patients

Sex: Male

Ages: 35 to 89 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

1,360 participants in 2 patient groups

Case Ascertainment

Description:

Men with prostate cancer

Treatment:

Diagnostic Test: Genetic Testing

Other: Laboratory Biomarker Analysis

Behavioral: Questionnaire

Other: Genetic Counseling

Procedure: Biospecimen Collection

Family Recruitment

Description:

Male relatives of men with prostate cancer

Treatment:

Diagnostic Test: Genetic Testing

Other: Laboratory Biomarker Analysis

Behavioral: Questionnaire

Other: Genetic Counseling

Procedure: Biospecimen Collection