Actively Recruiting
Predicting BReast cAncer Response to neoadjuVant Therapy by ctDNA Assessment
Led by Gene Solutions · Updated on 2025-09-23
125
Participants Needed
3
Research Sites
119 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective and observational study, aiming to determine the detection rate and change of CtDNA in blood samples of cancer patients before, during and after neoadjuvant treatment. * Determine the rate of ctDNA positivity at the time before treatment, * Determine the rate of ctDNA positivity at the time during treatment, * Determine the rate of ctDNA positivity at the time after neoadjuvant therapy, whether there is a change in ctDNA expression of the study population during treatment. And aiming to investigate the relationship between ctDNA expression and MRI imaging with pCR response in neo-adjuvant therapy: * Correlation between ctDNA detection and pCR response. Determine the percentage of Positive Prediction Value - PPV, Negative Prediction Value - NPV of ctDNA, * Correlation between MRI imaging and pCR response. Determination of PPV, NPV of MRI * Combination of ctDNA detection and MRI imaging in the prognosis of pCR. Determination of PPV, NPV ratio of ctDNA combined with MRI.
CONDITIONS
Official Title
Predicting BReast cAncer Response to neoadjuVant Therapy by ctDNA Assessment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female, 18 years old and older
- Diagnosed with stage II-III HER2-positive or triple-negative breast cancer
- Indicated for neoadjuvant chemotherapy
- Formalin-fixed paraffin-embedded (FFPE) tumor sample available at diagnosis and operation
- Voluntary agreement to participate in the study
You will not qualify if you...
- Recurrent breast cancer
- Other cancer metastasis to the breast
- Currently or previously treated for cancer
- Declined to participate in the study
AI-Screening
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Trial Site Locations
Total: 3 locations
1
MRCCC Siloam Hospitals Semanggi
Jakarta, Indonesia
Actively Recruiting
2
Medical Genetics Institute
Ho Chi Minh City, Vietnam
Actively Recruiting
3
University Medical Center HCMC
Ho Chi Minh City, Vietnam
Actively Recruiting
Research Team
L
Lan NL Tu, PHD
CONTACT
V
Van T. Phan, MSc
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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