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

Plain-language summary

This study uses genetic testing and genetic counseling to gather genetic information to guide treatment and screening in men diagnosed with prostate cancer. It enrolls men aged 35 to 89 diagnosed with prostate cancer who can provide a saliva sample, along with family members. It is a study without an assigned phase and enrolls by invitation.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Enrolling by invitation

Sponsor

Fred Hutchinson Cancer Center

Intervention

Questionnaire, Biospecimen Collection, Genetic Testing, Genetic Counseling, Laboratory Biomarker Analysis

Start date

11/30/2018

Estimated completion

8/31/2028

Countries

United States

Related genes

Locations

• Seattle, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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