RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-08-22
Study Completion:2027-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07025785

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
  2. 2. Subjects are willing and able to comply with study procedures based on the judgment of the investigator.
  3. 3. Age ≥ 18 years at time of consent.
  4. 4. Subject must have had surgical intervention and must have sufficient archival specimens from either the primary tumor or a lymph node for ctDNA assay development, as specified in the lab manual.
  1. 1. Subjects must not have had prior neoadjuvant therapy.
  2. 2. Evidence of metastatic disease in imaging.
  3. 3. N1 mic or isolated tumor cells in the lymph nodes

Contacts and Locations

Study Contact

Johnathan R Waugh
CONTACT
919-445-4872
jwaugh@email.unc.edu

Principal Investigator

Yara Abdou, MD
PRINCIPAL_INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center

Study Locations (Sites)

UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27514
United States

Collaborators and Investigators

Sponsor: UNC Lineberger Comprehensive Cancer Center

  • Yara Abdou, MD, PRINCIPAL_INVESTIGATOR, UNC Lineberger Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-22
Study Completion Date2027-08

Study Record Updates

Study Start Date2025-08-22
Study Completion Date2027-08

Terms related to this study

Keywords Provided by Researchers

  • circulating tumor DNA (ctDNA)
  • minimal residual disease (MRD)
  • African American

Additional Relevant MeSH Terms

  • Breast Cancer
  • Lymph Node Metastasis