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

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ClinicalTrials.gov Identifier: NCT04254133
Recruitment Status : Enrolling by invitation
First Posted : February 5, 2020
Last Update Posted : January 29, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center

Brief 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.

Condition or disease Intervention/treatment
Metastatic Prostate Carcinoma Stage IV Prostate Cancer AJCC v8 Stage IVB Prostate Cancer AJCC v8 Behavioral: Questionnaire Procedure: Biospecimen Collection Diagnostic Test: Genetic Testing Other: Genetic Counseling Other: Laboratory Biomarker Analysis

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine clinical, pathologic, and molecular predictors of germline DNA repair gene (gDRG) mutation carriers in a population-based cohort of men diagnosed with metastatic prostate cancer (mPC).

II. To characterize stepwise cascade genetic testing for at-risk male relatives of mPC cases with gDRG mutations.

III. To identify a cohort of men with gDRG mutations without a prostate cancer diagnosis who may benefit from an early detection protocol for prostate cancer. (Note: An early detection study for men with gDRG mutations without a prostate cancer diagnosis will be conducted as a separate trial.)

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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Study Type : Observational
Estimated Enrollment : 1360 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Genetic Information to Inform Treatment and Screening (GIFTS) Study for Prostate Cancer
Actual Study Start Date : November 30, 2018
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Case Ascertainment
Men with metastatic prostate cancer
Behavioral: Questionnaire
Complete questionnaire
Other Name: Questionnaires

Procedure: Biospecimen Collection
Provide saliva samples

Diagnostic Test: Genetic Testing
Undergo genetic testing
Other Names:
  • Genetic Analysis
  • Genetic Examination
  • Genetic Test

Other: Genetic Counseling
Undergo counseling

Other: Laboratory Biomarker Analysis
Correlative Studies

Family Recruitment
Male relatives of men with metastatic prostate cancer found to have a germline DNA Repair Gene mutation
Behavioral: Questionnaire
Complete questionnaire
Other Name: Questionnaires

Procedure: Biospecimen Collection
Provide saliva samples

Diagnostic Test: Genetic Testing
Undergo genetic testing
Other Names:
  • Genetic Analysis
  • Genetic Examination
  • Genetic Test

Other: Genetic Counseling
Undergo counseling

Other: Laboratory Biomarker Analysis
Correlative Studies




Primary Outcome Measures :
  1. Identification of a population-based cohort of men with mPC and germline DNA repair gene (gDRG) mutations [ Time Frame: From the start of study up to 5 years ]
    Identification to be determined through the Washington State Cancer Registry and by genetic testing on saliva samples for inherited mutations in cancer risk genes such as BRCA2, BRCA1, ATM, and others in metastatic prostate cancer.

  2. Clinical, pathologic, and molecular predictors of gDRG mutation carriers for men with mPC [ Time Frame: From the start of study up to 5 years ]
    Predictors to be identified by analyzing information provided by participants on their health history and potentially further testing or chart review on participants who consent to future contact.

  3. Utility and feasibility of cascade genetic testing through use of family history of men with mPC identified to have gDRG mutations [ Time Frame: From the start of study up to 5 years ]
    To be determined by collection of information about participants' family history and subsequent analysis of cascade genetic testing outcomes.

  4. Identification of a cohort of men with gDRG mutations without mPC [ Time Frame: From the start of study up to 5 years ]
    Identification to be determined through family history of men with mPC identified through the Washington State Cancer Registry and by genetic testing on saliva samples for inherited mutations in cancer risk genes such as BRCA2, BRCA1, ATM, and others in metastatic prostate cancer.



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients living in the 13-county region of northwestern Washington State with a new diagnosis of metastatic prostate cancer and first degree relatives of patients with a gDRG mutation
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04254133


Locations
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United States, Washington
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Heather H Cheng Fred Hutch/University of Washington Cancer Consortium
Principal Investigator: Daniel W Lin Fred Hutch/University of Washington Cancer Consortium
Principal Investigator: Colin C Pritchard Fred Hutch/University of Washington Cancer Consortium
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Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT04254133    
Other Study ID Numbers: RG1004177
P30CA015704 ( U.S. NIH Grant/Contract )
P50CA097186 ( U.S. NIH Grant/Contract )
NCI-2020-00933 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
8754 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: January 29, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases