Actively Recruiting

Age: 40Years +
All Genders
Healthy Volunteers
NCT05366881

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

Led by Adela, Inc · Updated on 2026-01-20

7000

Participants Needed

17

Research Sites

251 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 40Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Newly diagnosed (within 120 days) with cancer or a recurrence of a cancer diagnosed more than 5 years ago of one of the following types: invasive brain, breast, bladder, cervical, colorectal, endometrial, esophageal, gastric, head and neck, hepatobiliary, lung, ovarian, pancreatic, prostate, renal, sarcoma, thyroid, leukemia, lymphoma, or multiple myeloma
  • Able and willing to provide informed consent
  • 40 years of age or older
  • Not diagnosed with any cancer in the last 5 years for control participants (non-invasive cancer is allowed)
Not Eligible

You will not qualify if you...

  • Currently receiving any treatment for cancer
  • Currently taking any demethylating agents or DNA hypomethylating agents
  • Diagnosed with two or more invasive cancers at the same time
  • Diagnosed with any invasive or non-invasive cancer besides the main cancer in the last 5 years
  • Currently diagnosed with any chronic hematopoietic cancer in addition to the main cancer
  • Currently diagnosed with any myelodysplastic syndromes or precursor hematologic conditions in addition to the main cancer
  • Women known to be pregnant (self-reported)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 17 locations

1

City of Hope

Duarte, California, United States, 91010

Actively Recruiting

2

Miami Cancer Institute

Miami, Florida, United States, 33176

Actively Recruiting

3

North Georgia Health System

Gainesville, Georgia, United States, 306501

Actively Recruiting

4

Baptist Floyd

New Albany, Indiana, United States, 47150

Actively Recruiting

5

Baptist Corbin

Corbin, Kentucky, United States, 40701

Actively Recruiting

6

Baptist Hardin

Elizabethtown, Kentucky, United States, 42701

Actively Recruiting

7

Baptist Lexington

Lexington, Kentucky, United States, 40503

Actively Recruiting

8

Baptist Paducah

Paducah, Kentucky, United States, 42003

Withdrawn

9

Allina Health Cancer Institute

Minneapolis, Minnesota, United States, 55407

Actively Recruiting

10

Mayo Clinic

Rochester, Minnesota, United States, 55902

Actively Recruiting

11

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Actively Recruiting

12

Oregon Health Sciences University

Portland, Oregon, United States, 97201

Actively Recruiting

13

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Actively Recruiting

14

McLeod Health

Florence, South Carolina, United States, 29502

Actively Recruiting

15

Baptist (BHMCC)

Memphis, Tennessee, United States, 38120

Actively Recruiting

16

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States, 37203

Actively Recruiting

17

Elligo Health Research, Inc.

Austin, Texas, United States, 78704

Actively Recruiting

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Research Team

B

Brian Allen, MS

CONTACT

M

Michelle Anderson

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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