๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-01-13

Molecular Residual Disease Assessment in a Representative Diverse Population of Patients With Early-stage Breast Cancer (NCT07025785)

๐ŸŸข Recruiting Observational / Diagnostic ๐Ÿ“‹ Clinical Research Protocol Sponsor: UNC Lineberger Comprehensive Cancer Center

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

The purpose of this study is to determine how circulating tumor DNA (ctDNA), a sign of minimal residual disease (MRD), is detectable after surgery in patients with early HR+/HER2- breast cancer that has spread to 1-3 lymph nodes. Researchers aim to understand if ctDNA detection can identify patients at higher risk of recurrence and guide better treatment decisions. A key aspect is the inclusion of a dedicated cohort of African American/Black women, a group underrepresented in molecular residual disease (MRD) research despite experiencing more aggressive breast cancers. This study will correlate ctDNA results with treatment patterns (radiotherapy, systemic therapy) and outcomes (recurrence-free and overall survival) in both non-African American and African American participants.

Who can join: Review the eligibility criteria below.

Location: UNC Lineberger Comprehensive Cancer Center โ€” Chapel Hill, North Carolina

Age range: 18 Years

๐Ÿงช Interventions in This Study

  • Circulating tumor DNA (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 (1 Sites)

  • UNC Lineberger Comprehensive Cancer Center โ€” Chapel Hill, North Carolina

๐Ÿ“ž Contact the Study Coordinator

Phone: (919) 445-4872

Email: timothy_wilkinson@med.unc.edu

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.

Explore by condition: All Breast Cancer clinical trials

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†—