Clinical trial NCT04254133: Genetic Information to Inform Treatment and Screening for Prostate Cancer, GIFTS Study
Official title: Genetic Information to Inform Treatment and Screening (GIFTS) Study for Prostate Cancer
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Prostate Carcinoma
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-02-05
Enrollment: 1360
Sex: MALE
Minimum age (years): 35
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients living in Washington State with a new diagnosis of prostate cancer and first degree relatives of patients with prostate cancer

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

Eligibility 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

Primary outcomes:
measure: Identification of a population-based cohort of men with prostate cancer (PC) and germline deoxyribonucleic acid (DNA) repair gene (gDRG) mutations
timeFrame: From the start of study through death (up to 20 years)
measure: Clinical, pathologic, and molecular predictors of gDRG mutation carriers for men with PC
timeFrame: From the start of study through death (up to 20 years)
measure: Utility and feasibility of cascade genetic testing through use of family history of men with PC identified to have gDRG mutations
timeFrame: From the start of study through death (up to 20 years)
measure: Identification of a cohort of men with gDRG mutations without PC
timeFrame: From the start of study through death (up to 20 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Burcu Darst
role: PRINCIPAL_INVESTIGATOR
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Heather H Cheng
role: PRINCIPAL_INVESTIGATOR
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Daniel W Lin
role: PRINCIPAL_INVESTIGATOR
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Colin C Pritchard
role: PRINCIPAL_INVESTIGATOR
References: