An interventional study of Return of Genetic Results: Biomarker information from cancer cells and Return of Genetic Results: Inherited mutations related to cancer in Cholangiocarcinoma, Multiple Myeloma and Colon Cancer, sponsored by Washington University School of Medicine. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Health services research
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.
914 studies on the registry are indexed under Cholangiocarcinoma; 286 are open to participants now.
This study's planned enrollment of 990 is above the median of 50 across 687 interventional studies indexed under Cholangiocarcinoma.
Browse Cholangiocarcinoma studies →Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Eligibility Criteria:
Patients with cholangiocarcinoma, multiple myeloma, or early onset colon or rectal cancer.
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
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
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
Participants will receive a novel return of results report that is tailored to their choices.
Participants will receive a novel return of results report that is tailored to their choices.
Participants will receive a novel return of results report that is tailored to their choices.
Participant knowledge of clinical genetic testing
11-item, Likert scale. This scale has 5 points ranging from strongly agree to strongly disagree. 1=Strongly Agree, 2=Agree, 3=Neither Agree nor Disagree, 4=Disagree, 5=Strongly Disagree for items (4, 6-11) are scored such that 'strong disagree' reflects a correct response and 'somewhat disagree' reflects a less confident correct response in the correct direction. Negatively worded items (items 1, 2, 3, and 5) are reverse scored so that 'strongly agree' reflects a correct response and 'somewhat agree' reflect a less confident response in the correct direction. This will be scored by adding up the numbers for each of the 11 items regarding participant knowledge of clinical genetic testing. The total score ranges from 5 to 55. A higher score for the participant represents higher participant knowledge.
Time frame: Through completion of follow-up (estimated to be 5 years)
Participant expectations of benefit
Participants will rate their expectation for 6 potential benefits of cancer genomic sequencing on a 4-point scale ranging from extremely unlikely to extremely likely. . 1=Strongly Agree, 2=Agree, 3=Disagree, 4=Strongly Disagree. This will be scored by adding up the numbers for each of the 8 items regarding participant expectations of benefit. The total score ranges from 6 to 24. A higher score for the participant represents higher levels of expectations.
Time frame: Through completion of follow-up (estimated to be 5 years)
Participant personal utility
Participant personal utility will be measured on a 7-point scale ranging from not at all useful to extremely useful. 1=Not at all useful, 2=A little useful, 3=Somewhat useful, 4=Neutral, 5=Useful, 6=Very useful, 7=Extremely useful. This will be scored by adding up the numbers for each of the 14 items regarding participant personal utility. The total score ranges from 14 to 98. A higher score for the participant represents higher personal utility.
Time frame: Through completion of follow-up (estimated to be 5 years)
Participant anxiety
Participant anxiety will be measured using a 5-point Likert scale ranging from not at all to very much. 0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much. This will be scored by adding up the numbers for each of the 6 items regarding participant cancer worry. The total score ranges from 0 to 24. A higher score for the participant represents higher participant cancer worry.
Time frame: Through completion of follow-up (estimated to be 5 years)
Participant satisfaction
Satisfaction will be measured using a 5-point Likert scale ranging from extremely satisfied to not at all. 1=Not at all satisfied, 2=A little bit, 3=Somewhat, 4=Quite a bit, 5=Extremely satisfied. The total score ranges from 1 to 5. A higher score for the participant represents higher participant satisfaction.
Time frame: Through completion of follow-up (estimated to be 5 years)
Plan to share: Yes — Will share all data, software and know-how generated during the course of this work, without limitations except as prevented by prior agreement. This will include both the final datasets, as well as the data necessary to complete the aims. Will disseminate results from this research through presentations at public lectures, scientific institutions and meetings, and/or publication in major journals. All final peer-reviewed manuscripts that arise from this proposal will be submitted to the digital archive PubMed Central. Wherever applicable, data will be deposited to appropriate public repositories. All participants whose genomic data are collected will be consented for broad data sharing, and their genomic data will be included in the study deposits. Data documentation and de-identified data will be deposited for sharing along with phenotypic data, which includes demographics and diagnosis, consistent with applicable laws and regulations.
Supporting information: Study protocol, Sap
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