NCT06087120 Predicting BReast cAncer Response to neoadjuVant Therapy by ctDNA Assessment
| NCT ID | NCT06087120 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Gene Solutions |
| Condition | Breast Cancer Female |
| Study Type | OBSERVATIONAL |
| Enrollment | 125 participants |
| Start Date | 2023-09-16 |
| Primary Completion | 2025-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 125 participants in total. It began in 2023-09-16 with a primary completion date of 2025-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Sinh D Nguyen, PHD
PRINCIPAL INVESTIGATOR
MGI
Frequently Asked Questions
Who can join the NCT06087120 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer Female. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06087120 currently recruiting?
Yes, NCT06087120 is actively recruiting participants. Contact the research team at lantu@genesolutions.vn for enrollment information.
Where is the NCT06087120 trial being conducted?
This trial is being conducted at Jakarta, Indonesia, Ho Chi Minh City, Vietnam, Ho Chi Minh City, Vietnam.
Who is sponsoring the NCT06087120 clinical trial?
NCT06087120 is sponsored by Gene Solutions. The principal investigator is Sinh D Nguyen, PHD at MGI. The trial plans to enroll 125 participants.
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