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

The Washington University

Status: Enrolling

Conditions: Multiple Myeloma; Colon Cancer; Cholangiocarcinoma; Rectal Cancer

Treatments: Other: Return of Genetic Results: Biomarker information from cancer cells; Other: Return of Genetic Results: Inherited mutations related to cancer; Other: Return of Genetic Results: Inherited mutations related to other medical issues

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06340646

U2CCA252981 (U.S. NIH Grant/Contract)

202106129

Details and patient eligibility

About

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.

Enrollment: 990 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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990 participants in 2 patient groups

No Return of Genetic Results

No Intervention group

Description:

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

Return of Genetic Results

Experimental group

Description:

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

Treatment:

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

Other: Return of Genetic Results: Inherited mutations related to cancer

Other: Return of Genetic Results: Biomarker information from cancer cells