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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

∙ 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

Locations
United States
Missouri
Washington University School of Medicine
RECRUITING
St Louis
Contact Information
Primary
Graham Colditz, M.D., DrPH, MPH
colditzg@wustl.edu
314-454-7939
Backup
Bettina Drake, Ph.D., MPH
drakeb@wustl.edu
314-747-4534
Time Frame
Start Date: 2022-10-18
Estimated Completion Date: 2027-01-31
Participants
Target number of participants: 990
Treatments
No_intervention: No Return of Genetic Results
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
Experimental: Return of Genetic Results
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
Sponsors
Leads: Washington University School of Medicine
Collaborators: The Foundation for Barnes-Jewish Hospital, National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov