๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-11-05

Collection of Samples USOPTIVAL Study (NCT04792684)

Collection of Samples From the United States Population for Optimization and Evaluation of Colorectal Cancer (CRC) Plasma Circulating Free-DNA (cfDNA) Marker Panel Performance ("USOPTIVAL")

๐ŸŸข Recruiting Interventional Protocol ๐Ÿ“Š Observational Clinical Research Sponsor: Universal Diagnostics

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

A prospective multi-center observational study. The study will enroll eligible subjects from the United States to optimize the biomarker panel and evaluate the performance of a cfDNA marker panel selected by the Sponsor for CRC and advanced adenoma detection.

Who can join: Review the eligibility criteria below.

Location: Precision Recearch Institute โ€” Chula Vista, California

Age range: 45 Years to 84 Years

๐Ÿงช Interventions in This Study

  • Optimization of Plasma Circulating Free-DNA (cfDNA) Marker Panel (DIAGNOSTIC_TEST)

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (16 Sites)

  • Precision Recearch Institute โ€” Chula Vista, California
  • Precision Research Institute โ€” San Diego, California
  • Medical Associates Research Group โ€” San Diego, California
  • Clinical Research of California โ€” Walnut Creek, California
  • Center for Gastrointestinal Disorders โ€” Hollywood, Florida
  • Lakeland Regional Cancer Center โ€” Lakeland, Florida
  • Springfield Clinic โ€” Springfield, Illinois
  • Ochsner Clinic โ€” New Orleans, Louisiana
  • Dana Farber Cancer Institute โ€” Boston, Massachusetts
  • Mid Hudson Medical Research โ€” New Windsor, New York
  • University of Pennsylvania โ€” Philadelphia, Pennsylvania
  • Fox Chase Cancer Center โ€” Philadelphia, Pennsylvania
  • Frontier Clinical Research โ€” Uniontown, Pennsylvania
  • Clinical Trials Network โ€” Union City, Tennessee
  • Vilo Research Group โ€” Houston, Texas
  • Gastroenterology Consultants of SW Virginia โ€” Raonoke, Virginia

๐Ÿ“ž Contact the Study Coordinator

Phone: (+34)674945571

Email: antonio.merino@universaldx.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ 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 ยง 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.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—