Washington University Participant Engagement and Cancer Genomic Sequencing Center (WU-PE-CGS)

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT06340646
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Return of Genetic Results: Biomarker information from cancer cells — OTHER
    Participants will receive a novel return of results report that is tailored to their choices.
  • Return of Genetic Results: Inherited mutations related to cancer — OTHER
    Participants will receive a novel return of results report that is tailored to their choices.
  • Return of Genetic Results: Inherited mutations related to other medical issues — OTHER
    Participants will receive a novel return of results report that is tailored to their choices.

Study Details

The overall goal of the WU-PE-CGS is to build a rigorous, scientific evidence base for approaches that direct engagement of cancer patients and post-treatment cancer survivors as participants in cancer research, and to investigate the impact of directly engaging participants in decisions regarding returning of genomic results on participants' health and satisfaction. Participants in this study will be presented with the choice of types of genomic results to receive, and the Engagement Optimization Unit (EOU) will investigate the impact of this intervention on participant knowledge, expectations of benefit, personal utility, and decisional conflict.

Key Dates

Start date
Oct 18, 2022
Status verified
Jul 2025
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
990 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • No Intervention: No Return of Genetic Results
    Participants will undergo germline genomic sequencing as part of consenting to the WU-PE-CGS program. Participants will be given the option to receive the results from the genomic sequencing. After they consent to the study, the types of results available to them will be explained by research staff. Participants will be able to choose to receive: (1) no results, or any combination of (2) biomarker information from cancer cells, (3) inherited mutations related to cancer, and (4) inherited mutations related to other medical issues. These choices will be presented to them via a discussion with study staff with accompanying paper information
  • Experimental: Return of Genetic Results
    Participants will undergo germline genomic sequencing as part of consenting to the WU-PE-CGS program. Participants will be given the option to receive the results from the genomic sequencing. After they consent to the study, the types of results available to them will be explained by research staff. Participants will be able to choose to receive: (1) no results, or any combination of (2) biomarker information from cancer cells, (3) inherited mutations related to cancer, and (4) inherited mutations related to other medical issues. These choices will be presented to them via a discussion with study staff with accompanying paper information

Primary Outcome Measure

Participant knowledge of clinical genetic testing [ Time Frame: Through completion of follow-up (estimated to be 5 years) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Graham Colditz, M.D., DrPH, MPH
[email protected]
314-454-7939
Bettina Drake, Ph.D., MPH
[email protected]
314-747-4534
Graham Colditz, M.D., DrPH, MPH (PRINCIPAL_INVESTIGATOR)
Li Ding, Ph.D. (SUB_INVESTIGATOR)
Bettina Drake, Ph.D. (SUB_INVESTIGATOR)
Ryan Fields, M.D. (SUB_INVESTIGATOR)
Yin Cao, ScD, MPH (SUB_INVESTIGATOR)
Feng Chen, Ph.D. (SUB_INVESTIGATOR)
Patricia Dickson, M.D. (SUB_INVESTIGATOR)
Eric Duncavage, M.D. (SUB_INVESTIGATOR)
Mark Fiala, MSW (SUB_INVESTIGATOR)
Aimee James, Ph.D., MPH (SUB_INVESTIGATOR)
Reyka Jayasinge, Ph.D. (SUB_INVESTIGATOR)
Kian-Huat Lim, M.D., Ph.D. (SUB_INVESTIGATOR)
Erin Linnenbringer, Ph.D., MS (SUB_INVESTIGATOR)
Jessica Mozersky, Ph.D. (SUB_INVESTIGATOR)
Mary Politi, Ph.D. (SUB_INVESTIGATOR)
David Spencer, M.D., Ph.D. (SUB_INVESTIGATOR)
Tunji Toriola, M.D., Ph.D., MPH (SUB_INVESTIGATOR)
Ravi Vij, M.D., MBA (SUB_INVESTIGATOR)
Mark Watson, M.D., Ph.D. (SUB_INVESTIGATOR)
Fei Wan, Ph.D. (SUB_INVESTIGATOR)
Mike Wendl, DSC, MS, PHS (SUB_INVESTIGATOR)
Matthew Wyczalkowski, Ph.D. (SUB_INVESTIGATOR)
Stephanie Solomon Cargill, Ph.D., MSPH (SUB_INVESTIGATOR)

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