RecruitingNCT05366881

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

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


Sponsor

Adela, Inc

Enrollment

7,000 participants

Start Date

May 3, 2022

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a blood test that analyzes cell-free DNA (tiny fragments of DNA that float in the bloodstream) to detect cancer early and monitor treatment response. Researchers want to see how well this test can identify various cancers or detect whether cancer has returned after treatment. **You may be eligible if...** - You are 40 or older - You have been recently diagnosed with one of many cancer types (including breast, lung, colon, brain, bladder, cervical, stomach, and others) - OR you have not had cancer in the past 5 years (to serve as a healthy comparison) - You are willing to provide blood samples **You may NOT be eligible if...** - You are currently receiving cancer treatment at the time of enrollment - You are currently taking demethylating medications (a type of cancer drug) - You have been diagnosed with two or more invasive cancers at the same time - You have had any invasive cancer in the last 5 years (in addition to the cancer being studied) - You are known to be pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05366881


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