INSTIGO Trial: Evaluation of a Plasma Protein Profile as a Predictive Biomarker for Metastatic Relapse in Triple Negative Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Identification at diagnosis of a plasma protein profile predictive of metastatic relapse in patients with triple-negative breast cancer (TNBC)
研究概览
简要总结
The INSTIGO study aims to assess a plasma protein profile at different stages of patient follow-up as a predictive factor of metastatic recurrence in triple negative breast cancer. It also aims to look at other potential biomarkers of metastatic relapse such as Tumor-infiltrating Lymphocytes, circulating tumor DNA, figurative elements in blood, or a tumor RNA signature.
详细描述
The investigators propose to carry out a study that measures the concentrations of a set of plasma proteins in order to assess their ability to predict metastatic relapse of triple negative breast cancer. A plasma protein profile could be an interesting biomarker since it is easily accessible and quantifiable.
The investigators also propose to search relation between metastatic relapse in TNBC and other biomarkers or potential biomarkers such as Tumor-infiltrating Lymphocytes (TILs), figurative blood components and circulating tumour DNA (ctDNA).
Finally, they also want to validate a TNBC RNA signature, established at Jean PERRIN Center, by analyzing the RNA expression of 8 genes.
Before treatment begins, the patient will take an initial blood sample. A second blood sample will be taken on the day of the first surgery or the day of the surgery post chemotherapy. A third blood sample will be done on the day of the beginning of the radiotherapy. A 4th and a 5th blood sample will be done at 6 months and 1 year respectively after the end of the radiotherapy. A part of these blood samples will be used for the quantification of circulating proteins, for the determination of the blood's figurative elements and for the quantification of circulating tumour DNA.
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
- •Age > 18 years
- •Diagnosed with primitive, non-metastatic, histologically proved, triple negative breast cancer
- •Patient able to understand the French language
- •Patient affiliated to social security
- •Obtaining signed written consent
排除标准
- •Persons deprived of their freedom or under guardianship or incapable of giving consent
- •Refusal to participate
结局指标
主要结局
Identification at diagnosis of a plasma protein profile predictive of metastatic relapse in patients with triple-negative breast cancer (TNBC)
时间窗: 8 years
\- Time to metastatic relapse
次要结局
- Identification of a plasma protein profile predictive of metastatic relapse in patients with TNBC : on the day of primary surgery or post-chemotherapy surgery, the day the radiotherapy begins, at 6 months after radiotherapy and one year post-radiotherapy(8 years)
- Evaluation of the relationship between Platelet-to-lymphocyte Ratio (PLR) and Neutrophil-to-lymphocyte Ratio (NLR) and metastatic relapse(8 years)
- Evaluation of a metastatic relapse prognostic RNA signature for triple negative breast tumors(8 years)
- Identification of a characteristic plasma protein profile at the time of metastatic relapse(8 years)
- Evaluation of the relationship between the rate of tumour lymphocyte infiltration at diagnosis and metastatic relapse.(8 years)
- Evaluation of the relationship between ctDNA plasma levels and metastatic disease relapse(8 years)
- Identification at diagnosis of a plasma protein profile predictive of response to neoadjuvant chemotherapy(3 years and 6 months)
- Evaluation of the relationship between the rate of tumour lymphocyte infiltration at diagnosis and the response to a neoadjuvant chemotherapy .(3 years and 6 months)
- Evaluation of the relationship between Platelet-to-lymphocyte Ratio (PLR) and Neutrophil-to-lymphocyte Ratio (NLR) and the response to a neoadjuvant chemotherapy(3 years and 6 months)