Washington University Participant Engagement and Cancer Genomic Sequencing Center (WU-PE-CGS)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 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.
- Who it may be relevant to
- Registry conditions: Cholangiocarcinoma, Multiple Myeloma, Colon Cancer, Rectal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other Return of Genetic Results: Biomarker information from cancer cells
Participants will receive a novel return of results report that is tailored to their choices. - 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. - 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.
Primary outcome measures
- 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)]
Secondary outcome measures (2)
- Participant anxiety [Time frame: Through completion of follow-up (estimated to be 5 years)]
- Participant satisfaction [Time frame: Through completion of follow-up (estimated to be 5 years)]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- Washington University School of Medicine — St Louis
Identifiers
NCT: NCT06340646 · 202106129 · U2CCA252981