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

NCT ID: NCT06340646

Last Updated: 2025-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

990 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-18

Study Completion Date

2027-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cholangiocarcinoma Multiple Myeloma Colon Cancer Rectal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

Return of Genetic Results: Biomarker information from cancer cells

Intervention Type 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

Intervention Type 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

Intervention Type OTHER

Participants will receive a novel return of results report that is tailored to their choices.

Interventions

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Return of Genetic Results: Biomarker information from cancer cells

Participants will receive a novel return of results report that is tailored to their choices.

Intervention Type OTHER

Return of Genetic Results: Inherited mutations related to cancer

Participants will receive a novel return of results report that is tailored to their choices.

Intervention Type OTHER

Return of Genetic Results: Inherited mutations related to other medical issues

Participants will receive a novel return of results report that is tailored to their choices.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Eligibility Criteria:

* Patients with cholangiocarcinoma, multiple myeloma, or early onset colon or rectal cancer.

* If diagnosed with multiple myeloma, must be African-American.
* If diagnosed with colon or rectal cancer, must be African-American AND must be no older than 65 years old at the time of diagnosis.
* At least 18 years old
* Able to understand and willing to sign an IRB-approved written informed consent document
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

The Foundation for Barnes-Jewish Hospital

OTHER

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Graham Colditz, M.D., DrPH, MPH

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Graham Colditz, M.D., DrPH, MPH

Role: CONTACT

314-454-7939

Bettina Drake, Ph.D., MPH

Role: CONTACT

314-747-4534

Facility Contacts

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Graham Colditz, M.D., DrPH, MPH

Role: primary

314-454-7939

Bettina Drake, Ph.D., MPH

Role: backup

314-747-4534

Related Links

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http://www.siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Other Identifiers

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U2CCA252981

Identifier Type: NIH

Identifier Source: secondary_id

View Link

202106129

Identifier Type: -

Identifier Source: org_study_id

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