Analysis of the Evolution of Proteomic Profiles of Intestinal Microbiota in Patients With Locally Advanced or Metastatic Urothelial Carcinomas According to Their Response to Immunotherapy (Responders vs. Non-responders) : A Prospective Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 10
- 主要终点
- Stool sample collected from patients in the "cases" group
研究概览
简要总结
Immunotherapy has become an essential therapeutic weapon against many cancers. Control point inhibitors (CPI, PD-1/PD-L1) have shown efficacy in the therapeutic management of tumors in the bladder in progression after administering platinum derivatives. But only 20% of patients get any clinical benefit from these heavy treatments in the long term.
Treating metastatic patients without distinction means taking a considerable risk of toxicity and generates major costs. It is therefore urgent and important to exceed the current criteria for using immunotherapy. Recent studies have shown the interest of studying intestinal microbiota as a marker of the efficacy of immunotherapy.
The investigators hypothesized that the proteomic signature of the intestinal microbiota in patients with locally advanced or metastatic urothelial carcinomas who responded to immunotherapies was special, and has very different characteristics from that of patients with the same pathology who do not respond to immunotherapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •For the "controls" group:
- •Patients undergoing treatment for a locally advanced or metastatic urothelial tumor
- •Patients who have been on immunotherapy and 2nd-line monotherapy treatment for at least 6 months for a non-operable disease
- •Patients whose immunotherapy has been interrupted due to progression of the disease
- •For the "cases" group:
- •patients being treated in the context of a temporary authorization for use delivered for atezolizumab for the management of locally advanced or metastatic urothelial carcinomas following treatment based on platinum salts and still on treatment or patients being treated with pembrolizumab in the context of a donation for compassionate reasons (and still on treatment).
排除标准
- •Patients who do not speak or read the French language.
- •Patients in an exclusion period determined by another study.
- •Patients under legal guardianship or curatorship.
- •Patients for whom it is impossible to give clear information to.
研究组 & 干预措施
Cases
Patients who have been responding to treatment for a long time
干预措施: Blood test (Biological)
Cases
Patients who have been responding to treatment for a long time
干预措施: Stool sample (Biological)
Cases
Patients who have been responding to treatment for a long time
干预措施: Questionnaires (Other)
Controls
Patients who do not respond to treatment
干预措施: Blood test (Biological)
Controls
Patients who do not respond to treatment
干预措施: Stool sample (Biological)
Controls
Patients who do not respond to treatment
干预措施: Questionnaires (Other)
结局指标
主要结局
Stool sample collected from patients in the "cases" group
时间窗: 24 hours before the patient's follow-up visit at 1 month +/- 7 days
Quantification of bacterial proteins as a reflection of the intestinal microbiota and human proteins in the patient's stools. These will be analyzed from 50mg of stools via mass spectrometry (ESI-Q combined with the Ultimate 3000 Nano liquid chromatography system, ThermoFisher Scientific).
Stool sample collected from patients in the "controls" group
时间窗: 24 hours before the patient's follow-up visit at 1 month +/- 7 days
Quantification of bacterial proteins as a reflection of the intestinal microbiota and human proteins in the patient's stools.These will be analyzed from 50mg of stools via mass spectrometry (ESI-Q combined with the Ultimate 3000 Nano liquid chromatography system, ThermoFisher Scientific).
次要结局
- Evolution over time in the quality of life of patients in the "cases" group - EQ5D-5L(At the end of study visit, 2 months +/- 15 days after inclusion)
- Immune system markers in patients with locally advanced or metastatic urothelial carcinomas in "cases" group patients.(At the follow-up visit, 1 month +/- 7 days after inclusion)
- Immune system markers in patients with locally advanced or metastatic urothelial carcinomas in "controls" group patients.(At the follow-up visit, 1 month +/- 7 days after inclusion)
- Evolution over time in the quality of life of patients in the "controls" group - EQ5D-5L(At the end of study visit, 2 months +/- 15 days after inclusion)
- Side-effects related to immunotherapy in "controls" group - patient's viewpoint.(At the end of study visit, 2 months +/- 15 days after inclusion)
- Evolution over time in the quality of life of patients in the "cases" group - EORTC QLQ-C30(At the end of study visit, 2 months +/- 15 days after inclusion)
- Evolution over time in the quality of life of patients in the "controls" group - EORTC QLQ-C30(At the end of study visit, 2 months +/- 15 days after inclusion)
- Side-effects related to immunotherapy in "cases" group - patient's viewpoint.(At the end of study visit, 2 months +/- 15 days after inclusion)
- Side-effects related to immunotherapy in "cases" group - clinician's viewpoint.(At the end of study visit, 2 months +/- 15 days after inclusion)
- Side-effects related to immunotherapy in "controls" group - clinician's viewpoint.(At the end of study visit, 2 months +/- 15 days after inclusion)