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RECRUITING
NCT06087120

Predicting BReast cAncer Response to neoadjuVant Therapy by ctDNA Assessment

Sponsor: Gene Solutions

View on ClinicalTrials.gov

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.

Official title: Investigate the Prognostic and Predictive Value of Circulating Tumor DNA (ctDNA) During Neoadjuvant Chemotherapy for Breast Cancer.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

125

Start Date

2023-09-16

Completion Date

2025-12-31

Last Updated

2025-09-23

Healthy Volunteers

No

Locations (3)

MRCCC Siloam Hospitals Semanggi

Jakarta, Indonesia

Medical Genetics Institute

Ho Chi Minh City, Vietnam

University Medical Center HCMC

Ho Chi Minh City, Vietnam