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RECRUITING
NCT05366881

cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease

Sponsor: Adela, Inc

View on ClinicalTrials.gov

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

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