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Monitoring Plasma Tumor DNA in Early-Stage Breast Cancer
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Summary
This study is being done to see if it is possible to use blood samples to predict response to treatment in breast cancer patients receiving preoperative (or neoadjuvant) therapy. Research has shown that most breast cancers release tumor-specific DNA into the blood (that is, DNA that is specific to the tumor cells or cancer). This DNA can be detected in blood testing known as plasma tumor-DNA or "ptDNA." This DNA is separate from that found in the blood and tissue samples which serve as the "instruction book" or "genetic code" for the cells that make-up the human body. The changes in ptDNA before and after treatment, as well as after surgery, may also help investigators to understand more about a patient's risk of cancer returning and long-term outcomes.
Official title: Plasma Tumor DNA and Pathologic Complete Response in Early-Stage, High-Risk Breast Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
229
Start Date
2016-07
Completion Date
2026-07
Last Updated
2025-07-17
Healthy Volunteers
No
Conditions
Interventions
ptDNA
Pre-operative blood samples for ptDNA will be collected at the time of diagnosis/prior to NAT, post-cycle 1/pre-cycle 2 of NAT, after all NAT/immediately before surgery, and post-operatively at 6, 12, 24, and 36 months, and annually thereafter if funding allows.
Tissue sample
Representative tissue sample will be collected from the diagnostic biopsy (in all participants) and definitive surgery (if available)
Locations (1)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States