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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-8 weeks after results have been received and one year after disclosure of results

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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