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Recruiting Observational

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

NCT05366881 · tracked via the Priya Life Science USA tracker
Sponsor
Adela, Inc
Phase
Observational
Started
2022-05-03
Last updated
2026-01-20

Condition(s) studied

Brain CancerBreast CancerBladder CancerCervical CancerColorectal CancerEndometrial CancerEsophageal CancerStomach CancerHead and Neck CancerHepatobiliary CancerLeukemiaLung CancerLymphomaMultiple MyelomaOvarian CancerPancreatic CancerProstate CancerRenal CancerSarcomaThyroid Cancer

Study summary

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.

Eligibility

Sex
ALL
Min age
40 Years
Max age
—
Healthy volunteers
Accepted
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)

Primary outcome measure(s)

  • Detection of cancer — 24 months
    Differentiation of cancer signals from cases and non-cancer signals from controls based on analysis of cfDNA using the genome-wide methylome enrichment platform

Trial sites (17)

FacilityCityRegionStatus
City of Hope Duarte California Recruiting
Miami Cancer Institute Miami Florida Recruiting
North Georgia Health System Gainesville Georgia Recruiting
Baptist Floyd New Albany Indiana Recruiting
Baptist Corbin Corbin Kentucky Recruiting
Baptist Hardin Elizabethtown Kentucky Recruiting
Baptist Lexington Lexington Kentucky Recruiting
Baptist Paducah Paducah Kentucky Withdrawn
Allina Health Cancer Institute Minneapolis Minnesota Recruiting
Mayo Clinic Rochester Minnesota Recruiting
Cleveland Clinic Cleveland Ohio Recruiting
Oregon Health Sciences University Portland Oregon Recruiting
Medical University of South Carolina Charleston South Carolina Recruiting
McLeod Health Florence South Carolina Recruiting
Baptist (BHMCC) Memphis Tennessee Recruiting
Vanderbilt-Ingram Cancer Center Nashville Tennessee Recruiting
Elligo Health Research, Inc. Austin Texas Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05366881 on ClinicalTrials.gov ↗ ← All trials in the USA