Prostate Cancer Clinical Trial

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

Summary

This research study invites men with prostate cancer that has spread to other parts of the body (metastatic prostate cancer) identified through the Washington State Cancer Registry to complete genetic testing looking for inherited genetic mutations in about 30 cancer-risk genes. Participants also fill out a survey on their health history and family history of cancer. After receiving their test results, participants who are found to have genetic mutations predisposing to higher cancer risk receive genetic counseling, and their adult male relatives are invited to complete genetic testing as well. The researchers seek to learn about factors that might predict a higher likelihood of having a mutation, to learn how best to facilitate "cascade" genetic testing for at-risk male relatives of men with metastatic prostate cancer who are found to have concerning genetic mutations, and finally, to identify men without a prostate cancer diagnosis but with high risk genetic mutations who may benefit from a more focused screening protocol for prostate cancer.

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Full Description

OUTLINE:

Participants with mPC identified through the Washington State Cancer Registry receive mail and phone invitations to participate. Participants complete a web-based or hard copy questionnaire on their health history and family history of cancer and are mailed a saliva collection kit. Saliva samples are mailed back to Color Genomics for genetic testing, and results are provided both to participants and to study researchers. Participants who are identified to have an inherited mutation in a DNA repair gene receive phone-based genetic counseling, and are also asked for permission to contact their adult male relatives. If permission is granted, those relatives receive mail and phone invitations to complete genetic testing in a similar fashion.

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Eligibility Criteria

Inclusion Criteria: Case Ascertainment

Signed informed consent form providing agreement for germline genetic testing, use and release of health and research information
Diagnosis of metastatic prostate cancer
Resident of the 13-county area of western Washington
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 and email address

Inclusion Criteria: Family Recruitment

Signed informed consent form (ICF) providing agreement for germline genetic testing, use and release of health and research information
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 and email 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

Study is for people with:

Prostate Cancer

Estimated Enrollment:

1360

Study ID:

NCT04254133

Recruitment Status:

Enrolling by invitation

Sponsor:

Fred Hutchinson Cancer Center

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There is 1 Location for this study

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Fred Hutch/University of Washington Cancer Consortium
Seattle Washington, 98109, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

1360

Study ID:

NCT04254133

Recruitment Status:

Enrolling by invitation

Sponsor:


Fred Hutchinson Cancer Center

How clear is this clinincal trial information?

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