cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease
Condition(s) studied
Study summary
This is an observational case-control study to train and validate a genome-wide methylome enrichment platform to detect multiple cancer types and to differentiate amongst cancer types. The cancers included in this study are brain, breast, bladder, cervical, colorectal, endometrial, esophageal, gastric, head and neck, hepatobiliary, leukemia, lung, lymphoma, multiple myeloma, ovarian, pancreatic, prostate, renal, sarcoma, and thyroid. These cancers were selected based on their prevalence and mortality to maximize impact on clinical care.
Additionally, the ability of the whole-genome methylome enrichment platform to detect minimal residual disease after completion of cancer treatment and to detect relapse prior to clinical presentation will be evaluated in lung cancer. This cancer was selected based on the existing clinical landscape and treatment availability.
Eligibility
Primary outcome measure(s)
- Detection of cancer — 24 months
Differentiation of cancer signals from cases and non-cancer signals from controls based on analysis of cfDNA using the genome-wide methylome enrichment platform
Trial sites (17)
| Facility | City | Region | Status |
|---|---|---|---|
| City of Hope | Duarte | California | Recruiting |
| Miami Cancer Institute | Miami | Florida | Recruiting |
| North Georgia Health System | Gainesville | Georgia | Recruiting |
| Baptist Floyd | New Albany | Indiana | Recruiting |
| Baptist Corbin | Corbin | Kentucky | Recruiting |
| Baptist Hardin | Elizabethtown | Kentucky | Recruiting |
| Baptist Lexington | Lexington | Kentucky | Recruiting |
| Baptist Paducah | Paducah | Kentucky | Withdrawn |
| Allina Health Cancer Institute | Minneapolis | Minnesota | Recruiting |
| Mayo Clinic | Rochester | Minnesota | Recruiting |
| Cleveland Clinic | Cleveland | Ohio | Recruiting |
| Oregon Health Sciences University | Portland | Oregon | Recruiting |
| Medical University of South Carolina | Charleston | South Carolina | Recruiting |
| McLeod Health | Florence | South Carolina | Recruiting |
| Baptist (BHMCC) | Memphis | Tennessee | Recruiting |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | Recruiting |
| Elligo Health Research, Inc. | Austin | Texas | Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05366881 on ClinicalTrials.gov ↗ ← All trials in the USA