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Genetic Results Return for Cancer Patients

N/A
Recruiting
Led By Graham Colditz, M.D., DrPH, MPH
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6-8 weeks after results have been received, and one year after disclosure of results
Awards & highlights

Summary

This trial aims to study how involving cancer patients and survivors in cancer research and allowing them to choose which genomic results they want to receive affects their health and satisfaction. Researchers will look at how this involvement impacts

Who is the study for?
This trial is for cancer patients or survivors with conditions like Multiple Myeloma, Colorectal Cancer, Bile Duct Cancer, and Colon Cancer. They will be involved in research by choosing what genetic results they want to receive about inherited mutations and biomarkers from their cancer cells.
What is being tested?
The study tests the effect of giving patients a choice in receiving their own genomic information. It looks at how this choice impacts their knowledge, expectations of benefit, personal utility, and decision-making process regarding health.
What are the potential side effects?
Since this trial involves returning genetic results rather than testing drugs or therapies, traditional physical side effects are not applicable. However, learning about one's genetic risks could have emotional or psychological impacts.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-8 weeks after results have been received and one year after disclosure of results
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-8 weeks after results have been received and one year after disclosure of results for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Participant expectations of benefit
Participant knowledge of clinical genetic testing
Participant personal utility
Secondary study objectives
Participant anxiety
Participant satisfaction

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Return of Genetic ResultsExperimental Treatment3 Interventions
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 II: No Return of Genetic ResultsActive Control1 Intervention
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

Find a Location

Who is running the clinical trial?

The Foundation for Barnes-Jewish HospitalOTHER
40 Previous Clinical Trials
5,432 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,010 Total Patients Enrolled
Washington University School of MedicineLead Sponsor
1,970 Previous Clinical Trials
2,307,633 Total Patients Enrolled
~544 spots leftby Jan 2027
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