Predicting BReast cAncer Response to neoadjuVant Therapy by ctDNA Assessment
Investigate the Prognostic and Predictive Value of Circulating Tumor DNA (ctDNA) During Neoadjuvant Chemotherapy for Breast Cancer.
Gene Solutions
125 participants
Sep 16, 2023
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- Female,18 years old and older,
- Are diagnosed with stage II-III HER2+/Triple Negative breast cancer and indicated for neoadjuvant chemotherapy,
- FFPE sample is available at the time of diagnosis and operation,
- Are voluntary to participate in the study.
Exclusion Criteria4
- Recurrent breast cancer,
- Other cancer metastasis to the breast,
- Have been or are being treated for cancer,
- Patients did not agree to participate in the studies.
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT06087120