Recruiting

Observational Study

Sponsor:

Washington University School of Medicine

Code:

NCT06340646

Conditions

Cholangiocarcinoma

Multiple Myeloma

Colon Cancer

Rectal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Return of Genetic Results: Biomarker information from cancer cells

Return of Genetic Results: Inherited mutations related to cancer

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

Study Details

Brief summary:

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.

Conditions

Cholangiocarcinoma

Multiple Myeloma

Colon Cancer

Rectal Cancer

Study ID

NCT06340646

Start date

Oct 18, 2022

Status verified date

Jul, 2026

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

990 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

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

Interventions

Return of Genetic Results: Biomarker information from cancer cells

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

Return of Genetic Results: Inherited mutations related to cancer

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

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Graham Colditz, M.D., DrPH, MPH

314-454-7939colditzg@wustl.edu

Bettina Drake, Ph.D., MPH

314-747-4534drakeb@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Graham Colditz, M.D., DrPH, MPH

314-454-7939colditzg@wustl.edu

Bettina Drake, Ph.D., MPH

314-747-4534drakeb@wustl.edu

Principal Investigator:

Graham Colditz, M.D., DrPH, MPH

More Information

Sponsor

Washington University School of Medicine

Last update posted

Jul 14, 2026

Last verified

Jul, 2026

Keywords

  • Participant engagement
  • Genetic testing
  • Cholangiocarcinoma
  • Multiple Myeloma
  • Colorectal cancer
  • Underrepresented populations

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-07-14.