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

January 16, 2026 updated by: Adela, Inc

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

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 Overview

Status

Recruiting

Conditions

Detailed Description

This is an observational case-control study that includes individuals with cancer and individuals without known cancer. All participants will have clinical follow-up after enrollment. A subset of individuals with cancer will also have longitudinal blood sampling to evaluate the ability of the genome-wide methylome enrichment platform to detect minimal residual disease. This includes individuals with Stage I-III lung cancer (Tier 1 Cancers).

At baseline, all participants will provide a blood sample and applicable clinical data.

Participants with a Tier 1 cancer will have clinical follow-up and blood draws after the completion of first-line treatment, every 3 months for the first year after first-line treatment, and every 6 months for an additional 2 years. All other cases may have clinical follow-up once a year for 3 years after enrollment.

Control participants will have clinical follow-up every 6 months for up to 3 years from enrollment to evaluate cancer status.

The blood test to be used in this study is a highly sensitive, epigenomic-based genome-wide methylome enrichment platform. The assay includes bisulfite-free, non-degradative genome-wide DNA methylation profiling from small quantities of cell-free DNA (cfDNA). Libraries constructed from cfDNA are enriched for methylated CpGs and preserve the native fragment length. This is followed by high throughput sequencing.

For all assays, samples from participants with cancer and participants without cancer will be run together to reduce batch effects using methodology determined by the Sponsor. Results from the liquid biopsy test will not be returned to clinicians or participants.

Study Type

Observational

Enrollment (Estimated)

7000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope
        • Contact:
          • Xiao-Yu Xia
          • Phone Number: 626-218-0630
          • Email: xxia@coh.org
        • Principal Investigator:
          • Gregory Idos, MD
    • Florida
      • Miami, Florida, United States, 33176
    • Georgia
      • Gainesville, Georgia, United States, 306501
        • Recruiting
        • North Georgia Health System
        • Contact:
        • Principal Investigator:
          • Charles Nash, MD
    • Indiana
      • New Albany, Indiana, United States, 47150
        • Recruiting
        • Baptist Floyd
        • Contact:
        • Principal Investigator:
          • Amitoj Gill, MD
    • Kentucky
      • Corbin, Kentucky, United States, 40701
        • Recruiting
        • Baptist Corbin
        • Contact:
        • Principal Investigator:
          • Abigail Byrnes, MD
      • Elizabethtown, Kentucky, United States, 42701
        • Recruiting
        • Baptist Hardin
        • Contact:
        • Principal Investigator:
          • Christopher Burkeen, MD
      • Lexington, Kentucky, United States, 40503
        • Recruiting
        • Baptist Lexington
        • Contact:
        • Principal Investigator:
          • Arvinda Padmanabhan, MD
      • Paducah, Kentucky, United States, 42003
        • Withdrawn
        • Baptist Paducah
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
      • Rochester, Minnesota, United States, 55902
        • Recruiting
        • Mayo Clinic
        • Contact:
        • Principal Investigator:
          • Lisa A Boardman, MD
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
        • Principal Investigator:
          • Peter Mazzone, MD, MPH
    • Oregon
      • Portland, Oregon, United States, 97201
        • Recruiting
        • Oregon Health Sciences University
        • Principal Investigator:
          • Nima Nabavizadeh, MD
        • Contact:
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Principal Investigator:
          • Gerard Silvestri, MD
        • Contact:
        • Contact:
      • Florence, South Carolina, United States, 29502
        • Recruiting
        • McLeod Health
        • Contact:
        • Principal Investigator:
          • Virginia Clyburn-Ipock, MD
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Recruiting
        • Baptist (BHMCC)
        • Contact:
        • Principal Investigator:
          • Philip Lammers, MD
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Vanderbilt-Ingram Cancer Center
        • Contact:
        • Principal Investigator:
          • Brian Rini, MD
    • Texas
      • Austin, Texas, United States, 78704

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

This study will enroll individuals with newly diagnosed cancer as cancer cases and individuals without known cancer as controls. Participants will be enrolled from sites across the United States.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cases
Cases will include participants with newly diagnosed, treatment-naive cancer at the time of enrollment.
Controls
Controls will include participants without known cancer at the time of enrollment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of cancer
Time Frame: 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
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of specific cancer types
Time Frame: 24 months
Differentiation of cancer signals from cases with a specific cancer type and non-cancer signals from controls based on analysis of cfDNA using the genome-wide methylome enrichment platform
24 months
Tissue of origin
Time Frame: 18 months
Identification of the correct tissue of origin (as determined by clinical diagnosis) for cancer cases based on analysis of cfDNA using the genome-wide methylome enrichment platform
18 months
Clinical outcomes
Time Frame: 54 months
Recurrence-free survival and overall survival among cancer cases
54 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adela, Inc

Investigators

  • Principal Investigator: Brian Rini, MD, Vanderbilt-Ingram Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2022

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

May 3, 2022

First Submitted That Met QC Criteria

May 5, 2022

First Posted (Actual)

May 9, 2022

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Adela-EDMRD-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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