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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
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

Full criteria on ClinicalTrials.gov

Sites (17)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Elligo Health Research, Inc.
Coordinator of this site? Confirm its status
AustinUnited StatesCompleted
Medical University of South Carolina
Coordinator of this site? Confirm its status
CharlestonUnited StatesRecruiting
Cleveland Clinic
Coordinator of this site? Confirm its status
ClevelandUnited StatesCompleted
Baptist Corbin
Coordinator of this site? Confirm its status
CorbinUnited StatesCompleted
City of Hope
Coordinator of this site? Confirm its status
DuarteUnited StatesRecruiting
Baptist Hardin
Coordinator of this site? Confirm its status
ElizabethtownUnited StatesCompleted
McLeod Health
Coordinator of this site? Confirm its status
FlorenceUnited StatesCompleted
North Georgia Health System
Coordinator of this site? Confirm its status
GainesvilleUnited StatesCompleted
Baptist Lexington
Coordinator of this site? Confirm its status
LexingtonUnited StatesCompleted
Baptist (BHMCC)
Coordinator of this site? Confirm its status
MemphisUnited StatesCompleted
Miami Cancer Institute
Coordinator of this site? Confirm its status
MiamiUnited StatesCompleted
Allina Health Cancer Institute
Coordinator of this site? Confirm its status
MinneapolisUnited StatesCompleted
Vanderbilt-Ingram Cancer Center
Coordinator of this site? Confirm its status
NashvilleUnited StatesCompleted
Baptist Floyd
Coordinator of this site? Confirm its status
New AlbanyUnited StatesCompleted
Baptist Paducah
Coordinator of this site? Confirm its status
PaducahUnited StatesWithdrawn
Oregon Health Sciences University
Coordinator of this site? Confirm its status
PortlandUnited StatesRecruiting
Mayo Clinic
Coordinator of this site? Confirm its status
RochesterUnited StatesCompleted

This page is information, not medical advice. Discuss any trial with your doctor.