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cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease
Sponsor: Adela, Inc
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.
Official title: cfDNA Assay Multicenter Prospective Observational Validation for Early Cancer Detection, Minimal Residual Disease, and Relapse
Key Details
Gender
All
Age Range
40 Years - Any
Study Type
OBSERVATIONAL
Enrollment
7000
Start Date
2022-05-03
Completion Date
2027-03
Last Updated
2026-01-20
Healthy Volunteers
Yes
Conditions
Locations (17)
City of Hope
Duarte, California, United States
Miami Cancer Institute
Miami, Florida, United States
North Georgia Health System
Gainesville, Georgia, United States
Baptist Floyd
New Albany, Indiana, United States
Baptist Corbin
Corbin, Kentucky, United States
Baptist Hardin
Elizabethtown, Kentucky, United States
Baptist Lexington
Lexington, Kentucky, United States
Baptist Paducah
Paducah, Kentucky, United States
Allina Health Cancer Institute
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Cleveland Clinic
Cleveland, Ohio, United States
Oregon Health Sciences University
Portland, Oregon, United States
Medical University of South Carolina
Charleston, South Carolina, United States
McLeod Health
Florence, South Carolina, United States
Baptist (BHMCC)
Memphis, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Elligo Health Research, Inc.
Austin, Texas, United States