Trials Sponsors Conditions Drugs Pricing

Conditions

Metastatic Prostate Carcinoma Stage IV Prostate Cancer AJCC v8 Stage IVB Prostate Cancer AJCC v8

Keywords

Prostate cancermetastaticgenetic testingcancer riskBRCA1BRCA2

Outcome Measures

Primary Outcomes (4)

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
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
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

Study Arms (1)

Ancillary-Correlative (questionnaires, Color kit, counseling)

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 DNA repair gene. All participants have access to phone-based genetic counseling whether or not they are not found to have a mutation.

Procedure: Biospecimen CollectionOther: Genetic CounselingOther: Genetic TestingOther: Laboratory Biomarker AnalysisBehavioral: Questionnaire

Interventions

Biospecimen CollectionProcedure

Provide saliva samples

Ancillary-Correlative (questionnaires, Color kit, counseling)

Genetic CounselingOther

Undergo counseling

Ancillary-Correlative (questionnaires, Color kit, counseling)

Eligibility Criteria

Age18 Years+

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Participants with metastatic prostate cancer

You may qualify if:

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

Sponsors & Collaborators

National Cancer Institute (NCI)
NIHcollaborator
University of Washington
Otherlead

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Biospecimen

Retention: SAMPLES WITH DNA

Saliva

MeSH Terms

Conditions

Prostatic NeoplasmsNeoplasm Metastasis

Interventions

Genetic CounselingGenetic TestingSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

Heather H. Cheng
Fred Hutch/University of Washington Cancer Consortium
PRINCIPAL INVESTIGATOR

Enrollment

799 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: CASE ONLY
Time Perspective: CROSS SECTIONAL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 11, 2018

First Posted

April 19, 2018

Study Start

August 21, 2017

Actual (reported)

Study Stopped

Genetic Testing for Men With Metastatic Prostate Cancer

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Study Arms (1)

Ancillary-Correlative (questionnaires, Color kit, counseling)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Study Arms (1)

Ancillary-Correlative (questionnaires, Color kit, counseling)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations