Investigate the Prognostic and Predictive Value of Circulating Tumor DNA (ctDNA) During Neoadjuvant Chemotherapy for Breast Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 125
- 试验地点
- 3
- 主要终点
- Determine the detection rate and change of ctDNA in blood samples of cancer patients before, during, and after neoadjuvant treatment.
研究概览
简要总结
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.
详细描述
This is a prospective and observational study recruiting Female participants aged 18 and older, who are diagnosed with stage II-III HER+/Triple Negative Breast cancer and indicated for neoadjuvant chemotherapy at University Medical Center HCMC, had FFPE sample at the time of diagnosis and operation. This study is conducted at the Medical Genetics Institute (MGI), and MRCCC Siloam Hospitals Semanggi (Indonesia) in collaboration with the University Medical Center HCMC.
Eligible neoadjuvant chemotherapy (NAC) / treatment regimen for the study:
- AC-T (Doxorubicin, Cyclophosphamid - Taxane).
- AC-TH (Doxorubicin, Cyclophosphamid - Taxane - Trastuzumab).
- TCH (Docetaxel - Carboplatin - Trastuzumab).
- TCHP (Docetaxel - Carboplatin - Trastuzumab - Pertuzumab).
Patients are allowed to change protocol if required clinically.
The potential and voluntary participants, satisfy all the inclusion/exclusion criteria will be recruited into this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Determine the detection rate and change of ctDNA in blood samples of cancer patients before, during, and after neoadjuvant treatment.
时间窗: 12 months following up.
* 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.
To investigate the relationship between ctDNA expression and MRI imaging with pCR response in neo-adjuvant therapy.
时间窗: 12 months following up.
* 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.
次要结局
未报告次要终点