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MRD assessment in a diverse population of patients with early-stage breast cancer -DCT

This research study seeks to improve the treatment of early-stage breast cancer by examining circulating tumor DNA (ctDNA). CtDNA, a biomarker found in the blood, may indicate the presence of residual disease after initial treatment. The study aims to determine if ctDNA analysis can help doctors personalize adjuvant therapies, such as radiation and systemic therapy, leading to more effective treatment plans. A significant focus is placed on including African American/Black patients, a population often underrepresented in genomic research. By analyzing ctDNA in this group, researchers hope to gain valuable insights into the disease's characteristics and improve treatment outcomes, ultimately reducing disparities in breast cancer care. This is a hybrid decentralized study where some if not all assessments may be performed close to your home.

Age & Gender

  • 18 years ~ 99 years
  • Male, Female, Gender Inclusive

Visit Availability

  • Standard business hours (M-F, 8-5)

Location

United States (Nationwide)

What will be asked of you

This study includes 100 patients with early breast cancer who've had surgery. You'll join either the non-Black or Black participant group. Researchers will use your stored tumor tissue from surgery to create a test that detects circulating tumor DNA (ctDNA) in your blood. CtDNA can show if cancer cells remain after treatment. You'll give blood samples (about 3 tablespoons) when you start and roughly every three months for a year. These samples will be tested for ctDNA using Haystack Oncology's new method, a less invasive way to monitor your condition. You might give an extra sample before adjuvant treatment. Neither you nor your doctor will get the ctDNA test results because it's still experimental and not FDA-approved. The study is testing if this method accurately tracks the disease. Your doctor will still monitor you with standard tests. You can have blood drawn at your local clinic. Researchers at UNC-CH will use your stored tumor tissue. You can also choose to donate leftover tissue to a biobank for future research. By participating, you allow researchers to use your stored tissue and blood to study how ctDNA can help monitor and treat breast cancer. Only extra tissue and blood not needed for your care will be used. If your doctor needs to collect samples for your care, they may collect a little extra for this study.

In-person visits:
0-1
Phone or online visits:
0-1
Total length of participation:
12 months

Looking for Specific Volunteers

Able to participate:

  • You have confirmation of breast cancer with 1-3 positive lymph nodes.
  • You have had surgical intervention for early-stage breast cancer
  • You have not had any systemic or radiation treatment prior to surgery

Not eligible if:

  • You have had neoadjuvant therapy
  • You have evidence of metastatic disease
  • You have N1mi or isolated tumor cells in lymph node

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Yara Abdou
LCCC - Clinical Trials

Study Type

Clinical or Medical
Observational

Study Topics

Cancer (Breast)

IRB Number

25-1235

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