RecruitingNot applicableNCT05366881
Official study title

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

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.

Ask AI to explain this study
Start here

Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedNot specified

The study team can explain what participation involves.

Who it may be forBrain Cancer · Breast Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jan 20, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Not applicable

Observational

Where is it offered?17 U.S. locations

Locations may change over time.

Who runs it?Adela, Inc

Study sponsor

01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
Adela, Inc
Interventions being studied
Not specified
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Case
  • 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
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • City of HopeDuarte, California
  • Miami Cancer InstituteMiami, Florida
  • North Georgia Health SystemGainesville, Georgia
  • Baptist FloydNew Albany, Indiana
  • Baptist CorbinCorbin, Kentucky
  • Baptist HardinElizabethtown, Kentucky
  • Baptist LexingtonLexington, Kentucky
  • Baptist PaducahPaducah, Kentucky
  • Allina Health Cancer InstituteMinneapolis, Minnesota
  • Mayo ClinicRochester, Minnesota
  • Cleveland ClinicCleveland, Ohio
  • Oregon Health Sciences UniversityPortland, Oregon

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 20, 2026. Always confirm current availability with the study team.

View original record ↗