Validation of a blood test for early cancer detection and monitoring
cfDNA Assay Multicenter Prospective Observational Validation for Early Cancer Detection, Minimal Residual Disease, and Relapse
This study is testing a blood test to see if it can help find different types of cancer early and monitor patients after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 7000 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Adela, Inc Industry-sponsored |
| Locations | 17 sites (Duarte, California and 16 other locations) |
| Trial ID | NCT05366881 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 40 and older who have been newly diagnosed with specific types of invasive cancer.
Not a fit: Patients currently receiving cancer treatment or those with multiple invasive cancers may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a reliable blood test for early cancer detection and monitoring of treatment response.
How similar studies have performed: Other studies have shown promise in using liquid biopsies for cancer detection, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Duarte, California and 16 other locations
- City of Hope — Duarte, California, United States (Recruiting)
- Miami Cancer Institute — Miami, Florida, United States (Recruiting)
- North Georgia Health System — Gainesville, Georgia, United States (Recruiting)
- Baptist Floyd — New Albany, Indiana, United States (Recruiting)
- Baptist Corbin — Corbin, Kentucky, United States (Recruiting)
- Baptist Hardin — Elizabethtown, Kentucky, United States (Recruiting)
- Baptist Lexington — Lexington, Kentucky, United States (Recruiting)
- Baptist Paducah — Paducah, Kentucky, United States (Withdrawn)
- Allina Health Cancer Institute — Minneapolis, Minnesota, United States (Recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
- Oregon Health Sciences University — Portland, Oregon, United States (Recruiting)
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
- McLeod Health — Florence, South Carolina, United States (Recruiting)
- Baptist (BHMCC) — Memphis, Tennessee, United States (Recruiting)
- Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States (Recruiting)
- Elligo Health Research, Inc. — Austin, Texas, United States (Recruiting)
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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.