cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease (NCT05366881)
cfDNA Assay Multicenter Prospective Observational Validation for Early Cancer Detection, Minimal Residual Disease, and Relapse
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: City of Hope — Duarte, California
Age range: 40 Years
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (17 Sites)
- City of Hope — Duarte, California
- Miami Cancer Institute — Miami, Florida
- North Georgia Health System — Gainesville, Georgia
- Baptist Floyd — New Albany, Indiana
- Baptist Corbin — Corbin, Kentucky
- Baptist Hardin — Elizabethtown, Kentucky
- Baptist Lexington — Lexington, Kentucky
- Baptist Paducah — Paducah, Kentucky
- Allina Health Cancer Institute — Minneapolis, Minnesota
- Mayo Clinic — Rochester, Minnesota
- Cleveland Clinic — Cleveland, Ohio
- Oregon Health Sciences University — Portland, Oregon
- Medical University of South Carolina — Charleston, South Carolina
- McLeod Health — Florence, South Carolina
- Baptist (BHMCC) — Memphis, Tennessee
- Vanderbilt-Ingram Cancer Center — Nashville, Tennessee
- Elligo Health Research, Inc. — Austin, Texas
📞 Contact the Study Coordinator
Phone: (203) 514-4155
Email: brian.allen@adelabio.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.