Progression of NSCLC at All Stages of the Disease - Pathophysiological Mechanisms - Innovative Approaches to Translational Biology
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 150
- Primary Endpoint
- Molecular, metabolic, and immune mechanisms associated with tumor progression and relapse in NSCLC
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Arms & Interventions
Metastatic NSCLC with oncogenic addiction
Intervention: Translational analyses (Biological)
Localised NSCLC treated by neoadjuvant therapy followed by surgery
Intervention: Translational analyses (Biological)
Locally advanced NSCLC unaccessible to a surgery
Intervention: Translational analyses (Biological)
Metastatic NSCLC without oncogenic addiction
Intervention: Translational analyses (Biological)
Localised NSCLC treated by surgery +/- adjuvant therapy
Intervention: Translational analyses (Biological)
Outcomes
Primary Outcomes
Molecular, metabolic, and immune mechanisms associated with tumor progression and relapse in NSCLC
Time Frame: 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.
Secondary Outcomes
- 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)