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

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT07025785
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Circulating tumor DNA — DIAGNOSTIC_TEST
    Circulating tumor DNA (ctDNA) is a noninvasive prognostic biomarker for disease monitoring. ). Blood collection for ctDNA testing will be performed at the time of enrollment (prior to initiation of adjuvant therapy), and every three months thereafter.

Study Details

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.

Key Dates

Start date
Aug 22, 2025
Status verified
Jan 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: 1:Non African American
    50 Non-African American participants with lymph node-positive (1-3 LNs) early breast cancer (all subtypes).
  • Experimental: 2: African American
    50 African American participants with lymph node-positive (1-3 LNs) early breast cancer (all subtypes).

Primary Outcome Measure

Number of participants have post-operative circulating tumor DNA (ctDNA) positive [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UNC Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27514
Mireille Leone
[email protected]
919-984-0000
Paige Stem
[email protected]
Yara Abdou, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chapel Hill, NC

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
UNC Lineberger Comprehensive Cancer Center· Chapel Hill, NC

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