Predicting BReast cAncer Response to neoadjuVant Therapy by ctDNA Assessment
Recruiting · NCT06087120 · Observational (researchers observe without assigning treatment) · Lead sponsor: Gene Solutions
View the official record on ClinicalTrials.gov →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.
Who can take part
Inclusion criteria
- 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 criteria
- 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.
Where it is running
3 locations listed.
- Medical Genetics Institute - Ho Chi Minh City, Vietnam
- University Medical Center HCMC - Ho Chi Minh City, Vietnam
- MRCCC Siloam Hospitals Semanggi - Jakarta, Indonesia