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Predicting BReast cAncer Response to neoadjuVant Therapy by ctDNA Assessment

NCT06087120 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 125

Last updated 2025-09-23

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • Gene Solutions

    lead INDUSTRY

Principal Investigators

  • Sinh D Nguyen, PHD · MGI

  • Trung Q Lam, MD · University medical center HCMC

  • Samuel J Haryono, MD · MRCCC Siloam Hospitals Semanggi

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-16
Primary Completion
2025-12-01
Completion
2025-12-31

Countries

  • Indonesia
  • Vietnam

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06087120 on ClinicalTrials.gov