This clinical trial studies the impact of patient engagement strategies for cancer genome sequencing. Successful implementation of genomic sequencing in diverse patient settings requires adapting health information systems and garnering support from local stakeholders. The Washington University Patient Engagement and Cancer Genome Sequencing Center (WU-PE-CGS) brings together three research units, under the leadership of the Administrative Core, 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. Researchers want to look at different genes involved in cancer and how these genes work together to affect cancer growth, in hopes of finding new treatments for multiple myeloma, colorectal cancer, and cholangiocarcinoma. This study may also help researchers find out more about patient's thoughts on how results from genetic testing are presented and their preferences on how this information should be explained, to improve upon the way genetic testing results are presented.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06340646.
Locations matching your search criteria
United States
Missouri
Saint Louis
Siteman Cancer Center at Washington UniversityStatus: Active
Contact: Graham A. Colditz
Phone: 314-273-2434
PRIMARY OBJECTIVES:
I. 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.
II. To investigate the impact of directly engaging participants in decisions regarding returning of genomic results on participants’ health and satisfaction.
III. Identify, contact, consent, engage, and track participants in the WU-PE-CGS.
III. Collect archived (retrospective) and future (prospective) patient samples and track the use and quality of biospecimens.
IV. Determine the impact of the intervention of disclosure on participant health, satisfaction, knowledge, expectation of benefit, and decisional conflict.
V. Collect information from participants on the recruitment and consent process, barriers and facilitators to participation, and reasons for declining.
VI. Handle, process, and conduct quality control (QC) of biospecimens.
VII. Conduct clinical (Clinical Laboratory Improvement Amendments [CLIA] compliant) genomic sequencing and analysis.
VIII. Conduct research level genomic sequencing and analysis.
IX. Create participant reports detailing findings, including actionable events, and recommendations.
OUTLINE:
Patients undergo retrieval of existing leftover tissue, blood, or bone marrow samples as well as blood and saliva sample collection for genomic sequencing on study. Patients receive information explaining the different types and levels of genomic results available and choose a tailored report with the option of no results, or any combination of biomarker information from cancer cells, inherited mutations related to cancer, and inherited mutations related to other medical issues with an option to discuss the results with a genetic counselor on study.
Upone completion of intervention, patients are followed up annually for up to 5 years fo study duration.
Trial PhaseNo phase specified
Trial Typehealth services research
Lead OrganizationSiteman Cancer Center at Washington University
Principal InvestigatorGraham A. Colditz
