cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease
CAMPERR
cfDNA Assay Multicenter Prospective Observational Validation for Early Cancer Detection, Minimal Residual Disease, and Relapse
1 other identifier
observational
7,000
1 country
17
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2022
Longer than P75 for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2022
CompletedStudy Start
First participant enrolled
May 3, 2022
CompletedFirst Posted
Study publicly available on registry
May 9, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
ExpectedJanuary 20, 2026
January 1, 2026
3.8 years
May 3, 2022
January 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Detection of cancer
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 Outcomes (3)
Detection of specific cancer types
24 months
Tissue of origin
18 months
Clinical outcomes
54 months
Study Arms (2)
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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)
- 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
- Currently receiving any treatment for cancer
- Currently taking any demethylating agents/DNA hypomethylating agents
- Women who are known to be pregnant (self-reported)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Adela, Inclead
Study Sites (17)
City of Hope
Duarte, California, 91010, United States
Miami Cancer Institute
Miami, Florida, 33176, United States
North Georgia Health System
Gainesville, Georgia, 306501, United States
Baptist Floyd
New Albany, Indiana, 47150, United States
Baptist Corbin
Corbin, Kentucky, 40701, United States
Baptist Hardin
Elizabethtown, Kentucky, 42701, United States
Baptist Lexington
Lexington, Kentucky, 40503, United States
Baptist Paducah
Paducah, Kentucky, 42003, United States
Allina Health Cancer Institute
Minneapolis, Minnesota, 55407, United States
Mayo Clinic
Rochester, Minnesota, 55902, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Oregon Health Sciences University
Portland, Oregon, 97201, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
McLeod Health
Florence, South Carolina, 29502, United States
Baptist (BHMCC)
Memphis, Tennessee, 38120, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37203, United States
Elligo Health Research, Inc.
Austin, Texas, 78704, United States
Biospecimen
Plasma and extracted cell-free DNA
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brian Rini, MD
Vanderbilt-Ingram Cancer Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2022
First Posted
May 9, 2022
Study Start
May 3, 2022
Primary Completion
March 1, 2026
Study Completion (Estimated)
March 1, 2027
Last Updated
January 20, 2026
Record last verified: 2026-01