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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03503097
Other study ID # 9831
Secondary ID NCI-2018-0053398
Status Active, not recruiting
Phase
First received
Last updated
Start date August 21, 2017
Est. completion date August 21, 2024

Study information

Verified date February 2024
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This research study provides genetic testing to men with prostate cancer that has spread to other parts of the body (metastatic prostate cancer) and will look for inherited genetic mutations in about 30 cancer-risk genes. The researchers seek to learn about the participant's opinions and concerns about genetic testing, to determine if this is an acceptable way to deliver testing and to potentially help guide the participant's treatment. Neither treatment nor any decisions related to treatment will take place on this study, but researchers will share each participant's genetic testing results with that participant.


Description:

OUTLINE: Participants receive web-based or hard-copy questionnaires and saliva collection kits via mail or in person. Participants also provide saliva samples to be mailed back to Color Genomics for genetic testing once complete. Participants then receive phone-based genetic counseling if they are identified to have an inherited mutation in a deoxyribonucleic acid (DNA) repair gene. All participants have access to phone-based genetic counseling whether or not they are not found to have a mutation. After study completion, participants are followed up at 6 months.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 799
Est. completion date August 21, 2024
Est. primary completion date August 21, 2024
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - Signed informed consent form (ICF) providing agreement for germline genetic testing, use and release of health and research trial information - Documented evidence of metastatic prostate cancer; - Oncologist note within 4 months - All computed tomography (CT), bone, positron emission tomography (PET) scan reports within 12 months - All prostate-specific antigen (PSA) values within 12 months - All available pathology reports from diagnosis, prostatectomy, and/or metastatic biopsy - Willingness to provide basic demographic information, family cancer history, and treatment history - Willingness and ability to complete patient reported outcomes questionnaire (on-line or hard copy) at enrollment, and at 6-month follow-up - Willingness and ability to provide saliva sample Exclusion Criteria: - Unable or unwilling to provide all of the necessary information for eligibility, e.g. decisionally impaired - Incomplete inclusion criteria - Study team members

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Biospecimen Collection
Provide saliva samples
Other:
Genetic Counseling
Undergo counseling
Genetic Testing
Undergo genetic testing
Laboratory Biomarker Analysis
Correlative studies
Behavioral:
Questionnaire
Complete questionnaire

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
University of Washington National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of pathogenic germline homologous recombination (HR) variants in men with metastatic prostate cancer (mPC) Frequency to be determined by genetic testing on saliva samples for inherited mutations in cancer risk genes such as BRCA2, BRCA1, ATM, and others in metastatic prostate cancer. From the start of study up to 3 years
Primary Patient reported outcome measures associated with genetic testing in men with mPC Outcome measures to be defined by patient reported outcomes questionnaire (on-line or hard copy) at enrollment, and at 6-month follow-up. From the time of enrollment up to 6-month follow-up
Primary Utility of family history to enrich screening of participants with mPC for germline homologous recombination deficiency (HRD) variants defined by collection of information about research participants' family history To be determined by collection of information about research participants' family history that includes cancer history (diagnosis, age of onset, treatment, etc.) but will not include identifiers of family members. This information will be used to examine which self-reported family history criteria may be associated with identification of cancer predisposition syndrome. From the start of study up to 3 years
Primary Identification of a cohort of men with prostate cancer and inherited HRD mutations Identification to be determined through the Washington state cancer registry, through mail-out to all urologists and medical oncologists in the state of Washington, and through the Seattle Cancer Care Alliance Network sites. In addition, web-based advertising and recruiting will occur more broadly through the U.S., including at partnering sites. From the start of study up to 3 years
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