cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease
Public ClinicalTrials.gov record NCT05366881. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
cfDNA Assay Multicenter Prospective Observational Validation for Early Cancer Detection, Minimal Residual Disease, and Relapse
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05366881
- Recruitment status
- Recruiting
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 7,000 participants
Conditions and interventions
Conditions
- Brain Cancer
- Breast Cancer
- Bladder Cancer
- Cervical Cancer
- Colorectal Cancer
- Endometrial Cancer
- Esophageal Cancer
- Stomach Cancer
- Head and Neck Cancer
- Hepatobiliary Cancer
- Leukemia
- Lung Cancer
- Lymphoma
- Multiple Myeloma
- Ovarian Cancer
- Pancreatic Cancer
- Prostate Cancer
- Renal Cancer
- Sarcoma
- Thyroid Cancer
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 40 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 2, 2022
- Primary completion
- Feb 28, 2026
- Completion
- Feb 28, 2027
- Last update posted
- Jan 19, 2026
2022 – 2027
United States locations
- U.S. sites
- 17
- U.S. states
- 11
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | Recruiting |
| Miami Cancer Institute | Miami | Florida | 33176 | Recruiting |
| North Georgia Health System | Gainesville | Georgia | 306501 | Recruiting |
| Baptist Floyd | New Albany | Indiana | 47150 | Recruiting |
| Baptist Corbin | Corbin | Kentucky | 40701 | Recruiting |
| Baptist Hardin | Elizabethtown | Kentucky | 42701 | Recruiting |
| Baptist Lexington | Lexington | Kentucky | 40503 | Recruiting |
| Baptist Paducah | Paducah | Kentucky | 42003 | Withdrawn |
| Allina Health Cancer Institute | Minneapolis | Minnesota | 55407 | Recruiting |
| Mayo Clinic | Rochester | Minnesota | 55902 | Recruiting |
| Cleveland Clinic | Cleveland | Ohio | 44195 | Recruiting |
| Oregon Health Sciences University | Portland | Oregon | 97201 | Recruiting |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | Recruiting |
| McLeod Health | Florence | South Carolina | 29502 | Recruiting |
| Baptist (BHMCC) | Memphis | Tennessee | 38120 | Recruiting |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37203 | Recruiting |
| Elligo Health Research, Inc. | Austin | Texas | 78704 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05366881, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 19, 2026 · Synced Sep 14, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05366881 live on ClinicalTrials.gov.