NCT05366881Recruiting
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
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 7000 (estimated)
- First submitted
- 3 May 2022
- Start date
- 3 May 2022
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Adela, Inc
- Diseases
- Prostate cancer, Head and neck cancer, Thyroid cancer, Kidney cancer, Bladder cancer, Endometrial cancer, Cervical cancer, Lung cancer, Pancreatic cancer, Colorectal cancer, Gastric and esophageal cancer, Multiple myeloma, Ovarian cancer, Sarcoma
- NCT number
- NCT05366881
What you commit to
- Study type: Observational
- Planned participants: 7000
- From 3 May 2022 to the primary completion date, 31 Dec 2026
- 17 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Case Inclusion Criteria:
- Newly diagnosed (within 120 days) with cancer or a recurrence of a cancer diagnosed \>5 years ago of one of the following subtypes: Invasive Brain, Breast, Bladder, Cervical, Colorectal, Endometrial, Esophageal, Gastric, Head and Neck, Hepatobiliary, Lung, Ovarian, Pancreatic, Prostate, Renal, Sarcoma, Thyroid; Leukemia, Lymphoma, Multiple Myeloma
- Able and willing to provide informed consent
- ≥40 years of age
- Case Exclusion Criteria:
- Currently receiving any treatment for cancer
- Currently taking any demethylating agents/DNA hypomethylating agents
- Simultaneously diagnosed with two or more invasive cancers
- Diagnosed with any invasive or non-invasive cancer in addition to the index cancer in the last 5 years
- Currently diagnosed with any chronic hematopoietic cancer (e.g. chronic CLL) in addition to the index cancer
- Currently diagnosed with any myelodysplastic syndromes and/or precursor hematologic conditions (e.g. MGUS) in addition to the index cancer
- Women who are known to be pregnant (self-reported)
- Control Inclusion Criteria
- Not diagnosed with any cancer in the last 5 years (non-invasive cancer is allowed)
- Able and willing to provide informed consent
- ≥40 years of age
- Control Exclusion Criteria
- Currently receiving any treatment for cancer
- Currently taking any demethylating agents/DNA hypomethylating agents
- Women who are known to be pregnant (self-reported)
Age in the registry: 40 years to - · Sex: All · Accepts healthy volunteers
Sites (17)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Elligo Health Research, Inc. Coordinator of this site? Confirm its status | Austin | United States | Completed |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Recruiting |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Completed |
| Baptist Corbin Coordinator of this site? Confirm its status | Corbin | United States | Completed |
| City of Hope Coordinator of this site? Confirm its status | Duarte | United States | Recruiting |
| Baptist Hardin Coordinator of this site? Confirm its status | Elizabethtown | United States | Completed |
| McLeod Health Coordinator of this site? Confirm its status | Florence | United States | Completed |
| North Georgia Health System Coordinator of this site? Confirm its status | Gainesville | United States | Completed |
| Baptist Lexington Coordinator of this site? Confirm its status | Lexington | United States | Completed |
| Baptist (BHMCC) Coordinator of this site? Confirm its status | Memphis | United States | Completed |
| Miami Cancer Institute Coordinator of this site? Confirm its status | Miami | United States | Completed |
| Allina Health Cancer Institute Coordinator of this site? Confirm its status | Minneapolis | United States | Completed |
| Vanderbilt-Ingram Cancer Center Coordinator of this site? Confirm its status | Nashville | United States | Completed |
| Baptist Floyd Coordinator of this site? Confirm its status | New Albany | United States | Completed |
| Baptist Paducah Coordinator of this site? Confirm its status | Paducah | United States | Withdrawn |
| Oregon Health Sciences University Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.