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Predicting BReast cAncer Response to neoadjuVant Therapy by ctDNA Assessment

RECRUITINGSponsored by Gene Solutions
Actively Recruiting
SponsorGene Solutions
Started2023-09-16
Est. completion2025-12-01
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted

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

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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.

Conditions7

Breast CancerBreast Cancer FemaleCancerHER2-positive Breast CancerStage II Breast CancerStage III Breast CancerTriple Negative Breast Cancer

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