IMMUNO-LUNG : Identification of Biomarkers and Therapeutic Targets for Pulmonary Immunotherapy (IMMUNOLUNG)
IMMUNO-LUNG: Identification of Biomarkers and Therapeutic Targets for Pulmonary Immunotherapy - IMMUNOLUNG-IPC 2021-069
研究概览
详细说明
The primary objective of this clinical study is to understand how certain blood markers can predict the effectiveness of immunotherapy treatments for patients with advanced-stage lung cancer.
This is a multicenter study with a total duration of 7 years.
In addition, the study will address several secondary objectives:
Compare biological markers present in the blood with those found in lung cancer tumors.
Investigate differences between tumor markers at early versus advanced stages of the disease.
Identify new markers that may predict the effectiveness of immunotherapy treatments.
Explore a specific mechanism (called HVEM/BTLA) involved in lung cancer, whether at an early or advanced stage.
To achieve the study objectives, 200 patients are expected to be enrolled, and the study will be conducted across two institutions.
In this study, the following biological samples will be collected: blood and tissue samples at the time of inclusion, and again at disease progression if it occurs during follow-up.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Jihane pakradouni
- 电话号码：0491223824
- 邮箱：pakradounij@ipc.unicancer.fr
研究联系人备份
- 姓名：allison arthur
- 电话号码：0491223448
- 邮箱：arthura@ipc.unicancer.fr
学习地点
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Institut Paoli Calmettes
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Marseille、Institut Paoli Calmettes、法国、13009
- 招聘中
- Rochigneux
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接触：
- allison ARTHUR
- 电话号码：0491223448
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Patients aged 18 years or older, male or female.
- Willing to participate in the study and having signed a written informed consent form.
- Presenting a strong suspicion of localized resectable or advanced unresectable non-small cell lung cancer, or having a histologically confirmed non-small cell lung cancer.
- Affiliated with a social security system or benefiting from such a system.
Exclusion Criteria:
- Individuals in an emergency situation, adults under legal protection (guardianship, curatorship, or judicial protection), or individuals unable to provide informed consent.
- Inability to comply with the medical follow-up required by the study for geographical, social, or psychological reasons.
- History of solid organ transplantation or hematopoietic stem cell transplantation.
- Pregnant or breastfeeding women.
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：patients with localized NSCLC
This project is based on the prospective collection of blood and tumor samples from NSCLC patients, along with the corresponding clinical data.One hundred patients with localized NSCLC will be enrolled at each participating center; these are patients with resectable NSCLC treated by surgery.
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The procedure under study is based on the collection of tissue and blood samples at two time points during the patient's management. The patient will undergo a first sampling at the time of inclusion in the study, followed by a second sampling performed at the time of disease progression. Two types of samples will be collected: blood samples and tumor samples. The protocol-mandated tumor sampling at progression will be performed in the following two situations:
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其他：patients with advanced NSCLC
One hundred patients with advanced NSCLC will be enrolled at the center whose Principal Investigator is the scientific coordinator.
These are patients with unresectable NSCLC who are not eligible for surgery and whose initial treatment consists of medical therapy (chemotherapy and/or immunotherapy).
The samples are obtained using non-invasive techniques (mostly CT-guided biopsy and, less frequently, bronchoscopic or esophageal endoscopic biopsy).
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The procedure under study is based on the collection of tissue and blood samples at two time points during the patient's management. The patient will undergo a first sampling at the time of inclusion in the study, followed by a second sampling performed at the time of disease progression. Two types of samples will be collected: blood samples and tumor samples. The protocol-mandated tumor sampling at progression will be performed in the following two situations:
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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"The primary objective is to assess the association between the immune signature in peripheral blood and the efficacy of immunotherapies in patients with advanced-stage NSCLC
大体时间：until the patient's death"or until the end of the patient follow-up period, which is 60 months
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Overall survival of patients with advanced-stage NSCLC treated with immunotherapy according to their immune signature.
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until the patient's death"or until the end of the patient follow-up period, which is 60 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Compare immune biomarkers in the blood and in the tumor microenvironment of NSCLC patients
大体时间：through study completion, an average of 7 year
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Frequency of Immune Biomarkers in the Blood and Tumor Microenvironment of NSCLC
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through study completion, an average of 7 year
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Compare the expression of immune biomarkers in the tumor microenvironment of localized versus advanced NSCLC
大体时间：through study completion, an average of 7 year
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Frequency of Immune Biomarkers in the Tumor Microenvironment of Localized and Advanced NSCLC
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through study completion, an average of 7 year
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Identify new immune biomarkers predictive of immunotherapy efficacy in advanced NSCLC
大体时间：through study completion, an average of 7 year
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Frequency of Novel Immune Biomarkers According to Response to Immunotherapies in Advanced NSCLC
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through study completion, an average of 7 year
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Study the HVEM/BTLA axis in localized and advanced NSCLC
大体时间：through study completion, an average of 7 year
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Association between HVEM expression and overall survival in localized and advanced NSCLC
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through study completion, an average of 7 year
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Analyze co-signaling molecules, activating receptors, inhibitory receptors, as well as the maturation, exhaustion, and proliferation of anti-tumor immune cells, and cytokines
大体时间：through study completion, an average of 7 year
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Percentage expression of co-signaling molecules, activating receptors, inhibitory receptors, as well as maturation, exhaustion, and proliferation markers of anti-tumor immune cells by mass cytometry (Appendix 1).
Percentage expression of inflammatory cytokines by Luminex
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through study completion, an average of 7 year
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Analyze the impact of the tumor and its microenvironment on the phenotype of anti-tumor immune cells
大体时间：through study completion, an average of 7 year
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Levels of immune response in organoid cultures
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through study completion, an average of 7 year
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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