Pathophysiological Mechanisms Involved in the Pronostic and Evolution of Non-Small Cell Lung Cancer (NSCLC) at All Stages of the Disease

NCT07470476 | Not Yet Recruiting

• 1 other identifier: CHUBX 2024/108
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non Small Cell Lung Cancer

Keywords

Non small-cell lung cancer; Pathophysiology; Prognosis; Innovative therapies

Outcome Measures

Primary Outcomes (1)

• Molecular, metabolic, and immune mechanisms associated with tumor progression and relapse in NSCLC

  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.

  From diagnosis until death or study discontinuation, with a maximum follow-up of 10 years

Secondary Outcomes (1)

• 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

Study Arms (5)

Localised NSCLC treated by surgery +/- adjuvant therapy

Biological: Translational analyses

Localised NSCLC treated by neoadjuvant therapy followed by surgery

Biological: Translational analyses

Locally advanced NSCLC unaccessible to a surgery

Biological: Translational analyses

Metastatic NSCLC without oncogenic addiction

Biological: Translational analyses

Metastatic NSCLC with oncogenic addiction

Biological: Translational analyses

Interventions

Translational analyses BIOLOGICAL

Translational analyses of clinical data and biological samples

Localised NSCLC treated by neoadjuvant therapy followed by surgery; Localised NSCLC treated by surgery +/- adjuvant therapy; Locally advanced NSCLC unaccessible to a surgery; Metastatic NSCLC with oncogenic addiction; Metastatic NSCLC without oncogenic addiction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with Non-Small Cell Lung Cancer (NSCLC) at all stages of the disease

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and tumor tissue

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Charlotte DOMBLIDES

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte DOMBLIDES

CONTACT

+33556795808; charlotte.domblides@chu-bordeaux.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 13, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2036
• Study Completion (Estimated): June 1, 2041
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share