Observational Study for Early Cancer Detection Using cfDNA

This study is looking at a new blood test to find many types of cancer early and to see if cancer has returned after treatment. The test uses cell-free DNA (cfDNA), which are tiny pieces of DNA from cells that float in your blood. Researchers want to see if this test can accurately detect cancers like brain, breast, bladder, cervical, and colorectal cancer. They are also studying if it can find very small amounts of cancer remaining after treatment, especially for lung cancer. You can join if you are 40 or older and have been recently diagnosed with one of the listed cancers, or if you don't have cancer. The study aims to detect cancer within 24 months. The current recruitment status is unclear.

Study design
This is an observational study involving 7000 participants, including people with and without cancer. It is designed to compare the blood test results between these two groups.
What's involved
You will provide a blood sample and clinical information at the start. Some participants with lung cancer will have additional blood draws every 3-6 months for up to 3 years after treatment. Other participants may have yearly follow-up for 3 years.
Compensation
Not stated in the trial record.
Follow-up
Participants with certain cancers will have follow-up for up to 3 years after treatment. Control participants will have follow-up for up to 3 years to check for cancer status.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05366881

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

Recruiting
Not specifiedAges 40+Observational
Adela, Inc
~7,000 participants
Updated 2026-01-20 on ClinicalTrials.gov

At a glance

Recruiting sites
16 of 17 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Detection of cancer
Measured over 24 months
Brain Cancer
Breast Cancer
Bladder Cancer
Cervical Cancer
Colorectal Cancer
Endometrial Cancer
Esophageal Cancer
Stomach Cancer
Head and Neck Cancer
Hepatobiliary Cancer
Leukemia
Lung Cancer
Lymphoma
Multiple Myeloma
Ovarian Cancer
Pancreatic Cancer
Prostate Cancer
Renal Cancer
Sarcoma
Thyroid Cancer
17 sites across 11 states
Kentucky4
Minnesota2
South Carolina2
Tennessee2
California1
Florida1
Georgia1
Indiana1
  • Brian Rini, MD · PRINCIPAL_INVESTIGATOR · Vanderbilt-Ingram Cancer Center

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Eligibility criteria

Inclusion

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
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

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)
Currently receiving any treatment for cancer
Currently taking any demethylating agents/DNA hypomethylating agents
Women who are known to be pregnant (self-reported)
  • Detection of cancer24 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