Prognostic Value of Circulating Tumor DNA Dosing in Patients in Neoadjuvant Breast Neoplasia
试验速览
- 阶段
- 不适用
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- The concentration of circulating DNA(ctDNA)
研究概览
简要总结
This is a cohort, single-center, prospective study that seeks to analyze the circulating tumor DNA (ctDNA) in patients diagnosed with breast cancer, who will undergo neoadjuvant treatment.
详细描述
Breast cancer is a major public health problem, being the most common cancer in women worldwide. Breast cancer can be diagnosed through multiple tests, including an imaging and tissue biopsy. However, accurate assessment and prediction of the response is a major challenge. Circulating tumor DNA (ctDNA) has shown promise in the detection of breast cancer and clinical and cancer outcomes.
This study aims to evaluate a possible correlations between ctDNA levels with the pathological complete response and detection of residual disease after neoadjuvant therapy in patients with breast cancer.
In order to start ctDNA surveillance, patients will be asked to participate in blood draws, every 15 days, during neoadjuvant standard institutional treatment and allow study staff to review medical records.
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
- •Information to the patient and signed informed consent;
- •Locally advanced breast cancer that is a candidate for neoadjuvant therapy;
- •Histological diagnosis of localized invasive breast carcinoma, confirmed by the pathologist, with or without expression of hormone receptors, and/or with the presence of HER-2.
排除标准
- •Metastatic breast cancer (Stage IV);
- •Additional invasive malignant disease;
- •Known psychiatric or substance abuse disorders that may interfere with cooperation with study requirements;
- •Presents any organic condition that makes it impossible to carry out chemotherapy treatment;
- •Pregnant or lactating women
- •Received previous treatment for breast cancer.
结局指标
主要结局
The concentration of circulating DNA(ctDNA)
时间窗: From date of enrollment until the date of end of neoadjuvant treatment, assessed up to 6-7 months
Circulating tumor DNA (ctDNA) levels will be measured each 15 days until end of neoadjuvant therapy, through peripheral blood collection
次要结局
- Change from baseline ctDNA alterations to end of neoadjuvant treatment(Up to approximately 7 months starting from Baseline until end of neoadjuvant treatment)
研究者
Camila Giro
Principal Investigator
Instituto Brasileiro de Controle do Cancer