Progression of NSCLC at All Stages of the Disease - Pathophysiological Mechanisms - Innovative Approaches to Translational Biology
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 主要终点
- Molecular, metabolic, and immune mechanisms associated with tumor progression and relapse in NSCLC
研究概览
简要总结
This single-center observational cohort study conducted at Bordeaux University Hospital aims to establish a structured clinico-biological platform in non-small cell lung cancer (NSCLC) to investigate the biological mechanisms involved in tumor initiation, progression, and relapse across all disease stages (I-IV).
A total of 150 consecutive adult patients with histologically or cytologically confirmed NSCLC will be included over a 3-year period. Tumor samples will undergo translational analyses. These biological data will be correlated with pseudonymized clinical data collected from medical records and the institutional clinical data warehouse.
The primary objective is to characterize the molecular, metabolic, and immune mechanisms associated with tumor progression and recurrence in NSCLC.
The central hypothesis is that integrating comprehensive clinical data with in-depth molecular and immunological analyses of tumor tissues will identify biologically distinct patterns associated with disease evolution, therapeutic resistance, and prognosis. Such integrated clinico-biological signatures may improve patient stratification and contribute to the identification of novel biomarkers and therapeutic targets in NSCLC.
详细描述
Lung cancer remains one of the leading causes of cancer-related mortality worldwide. Despite major therapeutic advances over the past two decades, including targeted therapies and immune checkpoint inhibitors, long-term survival remains limited for a substantial proportion of patients. Although five-year survival has improved compared to the early 2000s, prognosis remains heterogeneous and largely dependent on tumor biology, stage at diagnosis, molecular alterations, and host-related factors.
Non-small cell lung cancer (NSCLC) accounts for approximately 85% of lung cancers and represents a biologically heterogeneous group of diseases. Tumor progression and resistance to therapy are driven by complex interactions between tumor cells, the tumor microenvironment, immune components, and host-related factors such as aging, smoking exposure, and chronic inflammatory lung diseases including chronic obstructive pulmonary disease (COPD).
A deeper understanding of these mechanisms is required to:
- Identify biomarkers associated with tumor progression and relapse
- Better predict therapeutic response and resistance
- Develop innovative diagnostic and therapeutic strategies
Bordeaux University Hospital is a regional referral center managing approximately 300-400 lung cancer patients annually. The institution hosts multiple academic research laboratories with expertise in tumor biology, immunology, thoracic diseases, and molecular oncology. This study aims to create a structured translational research continuum integrating clinical care and laboratory research.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Adult patients
- •NSCLC treated at the Bordeaux University Hospital.
- •TNM stage between I to IV
- •Patient affiliated with or beneficiary of a social security scheme.
- •Non opposition
排除标准
- •Patients with small cell lung cancer.
- •History of any other malignancy other than NSCLC within 1 years prior to screening. except for non-melanoma skin cancers, in situ cancers, or low-risk prostate cancer
- •Pregnant or breastfeeding women.
- •Patients with a medical or psychiatric condition or illness that compromises their ability to understand the information or participate in the study.
- •Individuals subject to legal protection measures (legal guardianship, trusteeship or curatorship).
- •Individuals deprived of their liberty by judicial or administrative decision.
- •Individuals who are unable to give their consent.
- •Patients who are in a period of exclusion following another study or who have participated in another interventional study involving a medicinal product within 30 days prior to entry into the protocol or who are participating in another clinical study.
研究组 & 干预措施
Metastatic NSCLC with oncogenic addiction
干预措施: Translational analyses (Biological)
Localised NSCLC treated by neoadjuvant therapy followed by surgery
干预措施: Translational analyses (Biological)
Locally advanced NSCLC unaccessible to a surgery
干预措施: Translational analyses (Biological)
Metastatic NSCLC without oncogenic addiction
干预措施: Translational analyses (Biological)
Localised NSCLC treated by surgery +/- adjuvant therapy
干预措施: Translational analyses (Biological)
结局指标
主要结局
Molecular, metabolic, and immune mechanisms associated with tumor progression and relapse in NSCLC
时间窗: From diagnosis until death or study discontinuation, with a maximum follow-up of 10 years
Comprehensive characterization of molecular alterations, metabolic profiles, and immune microenvironment features identified in tumor tissue samples (FFPE specimens), and their association with clinical indicators of disease progression or recurrence. Analyses will include correlation between biological signatures and progression-free survival, relapse occurrence, and overall survival across predefined disease stage cohorts.
次要结局
- Describe the results obtained in the various preclinical studies conducted in partnership with Inserm and CNRS/UBx teams.(From diagnosis until death or study discontinuation, with a maximum follow-up of 10 years)