cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease
NCT ID: NCT05366881
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
7000 participants
OBSERVATIONAL
2022-05-03
2027-03-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Cases
Cases will include participants with newly diagnosed, treatment-naive cancer at the time of enrollment.
No interventions assigned to this group
Controls
Controls will include participants without known cancer at the time of enrollment.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Able and willing to provide informed consent
* ≥40 years of age
* 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
Exclusion Criteria
* 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)
* Currently receiving any treatment for cancer
* Currently taking any demethylating agents/DNA hypomethylating agents
* Women who are known to be pregnant (self-reported)
40 Years
ALL
Yes
Sponsors
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Adela, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Brian Rini, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt-Ingram Cancer Center
Locations
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City of Hope
Duarte, California, United States
Miami Cancer Institute
Miami, Florida, United States
North Georgia Health System
Gainesville, Georgia, United States
Baptist Floyd
New Albany, Indiana, United States
Baptist Corbin
Corbin, Kentucky, United States
Baptist Hardin
Elizabethtown, Kentucky, United States
Baptist Lexington
Lexington, Kentucky, United States
Baptist Paducah
Paducah, Kentucky, United States
Allina Health Cancer Institute
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Cleveland Clinic
Cleveland, Ohio, United States
Oregon Health Sciences University
Portland, Oregon, United States
Medical University of South Carolina
Charleston, South Carolina, United States
McLeod Health
Florence, South Carolina, United States
Baptist (BHMCC)
Memphis, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Elligo Health Research, Inc.
Austin, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Adela-EDMRD-001
Identifier Type: -
Identifier Source: org_study_id
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