Validation of a blood test for early cancer detection and monitoring

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational case-control study aims to validate a genome-wide methylome enrichment platform for the early detection of multiple cancer types and to differentiate among them. Participants include individuals with newly diagnosed cancers and those without known cancer, with blood samples collected for analysis. The study focuses on detecting minimal residual disease and potential relapse in specific cancer types after treatment. Clinical follow-up will be conducted to monitor cancer status over several years.

Why it matters

Who can join: the full rules

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)

Where it's running

• City of Hope
  Duarte, California, United States Recruiting
• Oregon Health Sciences University
  Portland, Oregon, United States Recruiting
• Medical University of South Carolina
  Charleston, South Carolina, United States Recruiting
• Miami Cancer Institute
  Miami, Florida, United States Completed
• North Georgia Health System
  Gainesville, Georgia, United States Completed
• Baptist Floyd
  New Albany, Indiana, United States Completed

Study contacts

• Principal investigator: Brian Rini, MD — Vanderbilt-Ingram Cancer Center
• Study coordinator: Brian Allen, MS
• Email: brian.allen@adelabio.com
• Phone: 203-514-4155

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.