Actively Recruiting
cfDNA Assay Multicenter Prospective Observational Validation for Early Cancer Detection, Minimal Residual Disease, and Relapse
Led by Adela, Inc · Updated on 2026-01-20
7000
Participants Needed
17
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new blood test technology called the genome-wide methylome enrichment platform to detect multiple types of cancer and distinguish between them. This observational case-control study includes people with various cancers such as brain, breast, lung, and others selected for their high prevalence and mortality. The study also aims to assess the platform's ability to detect minimal residual disease and early relapse specifically in lung cancer after treatment. Participants in the study are divided into two groups: cases, who are newly diagnosed and have not yet received treatment for cancer, and controls, who have no known cancer. All participants will provide blood samples and clinical data at the start. Those with certain lung cancers will have additional blood draws and follow-ups every 3 to 6 months for up to 3 years after treatment. Controls will have follow-up visits every 6 months for up to 3 years to monitor cancer status. Throughout the study, blood samples from participants with and without cancer will be tested together using a sensitive, noninvasive DNA methylation profiling method that analyzes small amounts of cell-free DNA. Results from this liquid biopsy will not be shared with participants or their doctors. Researchers will track cancer detection over 24 months and monitor clinical outcomes for up to 54 months. Participants’ health status will be observed during follow-up visits to evaluate the test’s performance in detecting cancer early and identifying relapse.
CONDITIONS
Brief Title
cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed with cancer or recurrence diagnosed more than 5 years ago of specific types including 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
- At least 40 years old
- No diagnosis of cancer in the last 5 years for controls (non-invasive cancer allowed)
You will not qualify if you...
- Currently receiving any treatment for cancer
- Currently taking any demethylating or DNA hypomethylating agents
- Diagnosed with two or more invasive cancers at the same time
- Diagnosed with any invasive or non-invasive cancer in addition to the index cancer in the last 5 years
- Diagnosed with chronic hematopoietic cancers or myelodysplastic syndromes in addition to the index cancer
- Women who are pregnant (self-reported)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 1
At baseline, all participants provide a blood sample and applicable clinical data.
1 visit (in-person)
Duration - Up to 3 years
Participants are clinically followed to monitor cancer status or evaluate minimal residual disease depending on their group assignment.
Varies by group: Controls have visits every 6 months; participants with cancer have follow-up after first-line treatment, then every 3 months for the first year, and every 6 months for 2 additional years
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
Research Team
B
Brian Allen, MS
M
Michelle Anderson
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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