Trials / Not Yet Recruiting
Not Yet RecruitingNCT07332975
ctDNA Positive Patients Diagnosed With cT1bN0 and cT1cN0 TNBC
A Proportion of ctDNA Positive Patients Diagnosed With cT1bN0 and cT1cN0 TNBC (ARES)
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 77 (estimated)
- Sponsor
- University of Pittsburgh · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This translational biomarker study will collect blood in patients Stage I triple negative breast cancer at diagnosis prior to either neoadjuvant treatment or surgery and then during treatment.
Detailed description
A highly sensitive, tumor-informed method of detecting circulating free DNA (cfDNA) shed by solid tumors has been developed. Plasma will be assayed for ctDNA using the SaferSeqS tumor-informed assay employing DNA sequences derived from breast biopsies and/ or surgery specimens. The abundance and molecular characteristics of ctDNA will be evaluated in 77 patients using optimum Simon Stage II statistical design.
Conditions
Timeline
- Start date
- 2026-01-31
- Primary completion
- 2029-01-31
- Completion
- 2029-01-31
- First posted
- 2026-01-12
- Last updated
- 2026-01-12
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT07332975. Inclusion in this directory is not an endorsement.