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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Bordeaux

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Translational analyses

    Biological/Vaccine

    Translational analyses of clinical data and biological samples

Treatment groups

150 Participants
are divided into 5 treatment groups
Group A: Localised NSCLC treated by surgery +/- adjuvant therapy1 intervention
Group B: Localised NSCLC treated by neoadjuvant therapy followed by surgery1 intervention
Group C: Locally advanced NSCLC unaccessible to a surgery1 intervention
Group D: Metastatic NSCLC without oncogenic addiction1 intervention
Group E: Metastatic NSCLC with oncogenic addiction1 intervention

Trial outcomes

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.

Time frame
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.

Identification of biological links between precancerous conditions, including Chronic Obstructive Pulmonary Disease (COPD) and bronchial remodeling, and the development of non-small cell lung cancer; Characterization of the immunosuppressive tumor microenvironment in non-small cell lung cancer and its impact on prognosis and treatment response; Identification of aging-related biomarkers in elderly patients with non-small cell lung cancer to optimize and personalize treatment strategies; Investigation of the specific functions of the secretome in non-small cell lung cancer.

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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