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Not yet recruitingNCT07470476EMAUpdated Apr 17, 2026

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

An observational study in Non Small Cell Lung Cancer, sponsored by University Hospital, Bordeaux. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-17.

Sponsored by University Hospital, Bordeaux · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
150
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

Clinical data will be extracted from:

  • The institutional clinical data warehouse
  • Electronic medical records

Data collected will include:

  • Demographics and smoking history
  • Comorbidities (including COPD and other lung diseases)
  • Tumor histology and molecular characteristics
  • TNM staging
  • Treatment modalities (surgery, radiotherapy, systemic therapies)
  • Treatment response and toxicity
  • Recurrence, progression, and survival outcomes Clinical data will be pseudonymized and recorded in a dedicated REDCap electronic case report form hosted at Bordeaux University Hospital.

Clinico-biological correlation analyses will make it possible to define :

  • Response in study patients and evaluation of the impact of the different biological factors on treatment response, assessed according to RECIST 1.1 criteria
  • Prognostic analyses may also be performed on overall survival (time between inclusion and death/loss to follow-up) and progression-free survival (time between inclusion and progression/loss to follow-up/death)
  • Survival of patients in the cohort (overall survival, progression-free survival)
  • Response rate of patients in the cohort according to treatment
  • Factors statistically associated with survival using univariate then multivariate Cox analysis
  • Treatment tolerance (descriptive analysis)
  • List of pathways involved in resistance processes, and description of newly identified therapeutic targets for the different treatments
  • Validation of the functional involvement of proteins/pathways in in vitro models

Biological Samples and Translational Analyses Tumor samples consist of formalin-fixed paraffin-embedded (FFPE) biopsy or surgical specimens stored at the institutional Biological Resource Center.

Samples will undergo translational analyses in partner academic laboratories, including:

  • Molecular characterization of tumor cells
  • Metabolic profiling
  • Characterization of the tumor immune microenvironment
  • Evaluation of immunosuppressive pathways
  • Analysis of secretome-related functions
  • Identification of aging-related biological signatures

After analysis, biological data will be securely transferred to the coordinating center and correlated with clinical variables.

All samples and associated data will be pseudonymized in accordance with applicable data protection regulations.

02

Conditions studied

  • Non Small Cell Lung Cancer

Keywords

  • Non small-cell lung cancer
  • Pathophysiology
  • Prognosis
  • Innovative therapies
03

In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's planned enrollment of 150 is close to the median of 161 across 949 observational studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

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

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.
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
150 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • BiologicalTranslational analyses

    Translational analyses of clinical data and biological samples

06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07470476
Lead sponsor
University Hospital, Bordeaux
Responsible party
Sponsor
First posted
Mar 13, 2026
Start date
Jun 2026 (estimated)
Primary completion
Jun 2036 (estimated)
Completion
Jun 2041 (estimated)
Last update
Apr 17, 2026

Study contacts

Charlotte DOMBLIDES
Contact
charlotte.domblides@chu-bordeaux.fr
+33556795808
Charlotte DOMBLIDES
principal investigator · University Hospital, Bordeaux

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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