Study of Prognostic Value of T Cell Receptor Diversity and CD4 Lymphopenia in First Relapse Breast or Lung Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 179
- 试验地点
- 4
- 主要终点
- Analyse the prognostic value of divpenia
研究概览
简要总结
The T and B cells repertoire diversity represent one of the immune defence level which controls the integrity of the organism and determines its ability to recognize and control infectious attacks and development of tumours. The study of the lymphocytes TCR and BCR diversity could permit to better understand how lymphopenia act on overall survival and to improve detection of high risk patients who could benefit of adapted therapies for better care.
详细描述
The therapeutic management recommendations of patients with metastatic cancer offer standard treatment in specific situations. But, there is always a subgroup of patients who do not benefit from treatment and which has a very low survival. The risk of death for patients is very variable depending on the initial cancer site, tumor aggressiveness and chemosensitivity of tumours.
It's therefore important to have relevant prognostic tools to predict such an excess of relative toxicity or drug resistance. Simple prognostic factors for survival as the performance status (PS) have already been highlighted in several studies. Thus, the possibility to identify a group of patients with a higher risk of mortality could be of major interest for clinicians. In fact such stratification will allow:
- To limit this risk by adjusting the therapy and/or associated treatments (antibiotic prophylaxis, dose reduction ...),
- To develop protocols for testing innovative strategies specific to this high risk population.
The objectives of these innovative protocols would be designed to correct lymphodivpenia.
The main objective is to show that T divpenia (low TCR combinatorial diversity <30%) is a risk factor for early death after chemotherapy (early death: any death occurring within 3 months (lung cancer) or within 6 months (breast cancer) after the start of chemotherapy).
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
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old,
- •Patients with an histologically proven, inoperable breast or lung tumour,
- •Metastatic disease before the start of any chemotherapy,
- •Signed written informed consent form,
- •Covered by a medical insurance,
- •Patient accepting the conservation of biological samples,
- •Locally advanced incurable disease (only breast tumour).
排除标准
- •Hematological tumour,
- •Auto-immune disease (including HIV-positive - AIDS stage) or patients with immunosuppressive therapy,
- •Metastatic disease that had progressed after a first line chemotherapy,
- •Pregnant or lactating female or female of child-bearing potential not employing adequate contraception,
- •Patient deprived of liberty by a judicial or administrative,
- •Adult protected by law.
结局指标
主要结局
Analyse the prognostic value of divpenia
时间窗: 3 month (lung cancer) 6 month (breast cancer)
To show that T divpenia (low TCR combinatorial diversity \<30%) is a risk factor for early death after chemotherapy (early death: any death occurring within 3 months (lung cancer) or within 6 months (breast cancer) after the start of chemotherapy).
次要结局
- Analyse prognostic value of clinico-biological parameters (PS ECOG, LDH levels, - To establish that the divpenia factor is independent of clinical and biological prognostic factors (PS, LDH, metastasis localization, Hb, PMN, age, sex)(3 month (lung cancer) - 6 month (breast cancer))
- Prognostic score NDL(3 month (lung cancer) - 6 month (breast cancer))
- Characterization of other circulating markers(3 month (lung cancer) - 6 month (breast cancer))