Trial Title:
Washington University Participant Engagement and Cancer Genomic Sequencing Center (WU-PE-CGS)
NCT ID:
NCT06340646
Condition:
Cholangiocarcinoma
Multiple Myeloma
Colon Cancer
Rectal Cancer
Conditions: Official terms:
Multiple Myeloma
Cholangiocarcinoma
Conditions: Keywords:
Participant engagement
Genetic testing
Cholangiocarcinoma
Multiple Myeloma
Colorectal cancer
Underrepresented populations
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Return of Genetic Results: Biomarker information from cancer cells
Description:
Participants will receive a novel return of results report that is tailored to their
choices.
Arm group label:
Return of Genetic Results
Intervention type:
Other
Intervention name:
Return of Genetic Results: Inherited mutations related to cancer
Description:
Participants will receive a novel return of results report that is tailored to their
choices.
Arm group label:
Return of Genetic Results
Intervention type:
Other
Intervention name:
Return of Genetic Results: Inherited mutations related to other medical issues
Description:
Participants will receive a novel return of results report that is tailored to their
choices.
Arm group label:
Return of Genetic Results
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Washington University School of Medicine
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Contact:
Last name:
Graham Colditz, M.D., DrPH, MPH
Phone:
314-454-7939
Email:
colditzg@wustl.edu
Contact backup:
Last name:
Bettina Drake, Ph.D., MPH
Phone:
314-747-4534
Email:
drakeb@wustl.edu
Investigator:
Last name:
Graham Colditz, M.D., DrPH, MPH
Email:
Principal Investigator
Investigator:
Last name:
Li Ding, Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Bettina Drake, Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Ryan Fields, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Yin Cao, ScD, MPH
Email:
Sub-Investigator
Investigator:
Last name:
Feng Chen, Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Kia Davis, ScD, MPH
Email:
Sub-Investigator
Investigator:
Last name:
Patricia Dickson, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Eric Duncavage, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Mark Fiala, MSW
Email:
Sub-Investigator
Investigator:
Last name:
Aimee James, Ph.D., MPH
Email:
Sub-Investigator
Investigator:
Last name:
Reyka Jayasinge, Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Kian-Huat Lim, M.D., Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Erin Linnenbringer, Ph.D., MS
Email:
Sub-Investigator
Investigator:
Last name:
Jessica Mozersky, Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Mary Politi, Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
David Spencer, M.D., Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Tunji Toriola, M.D., Ph.D., MPH
Email:
Sub-Investigator
Investigator:
Last name:
Ravi Vij, M.D., MBA
Email:
Sub-Investigator
Investigator:
Last name:
Mark Watson, M.D., Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Fei Wan, Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Mike Wendl, DSC, MS, PHS
Email:
Sub-Investigator
Investigator:
Last name:
Matthew Wyczalkowsi, Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Stephanie Solomon Cargill, Ph.D., MSPH
Email:
Sub-Investigator
Start date:
October 18, 2022
Completion date:
January 31, 2027
Lead sponsor:
Agency:
Washington University School of Medicine
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Collaborator:
Agency:
The Foundation for Barnes-Jewish Hospital
Agency class:
Other
Source:
Washington University School of Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06340646
http://www.siteman.wustl.edu
