NCT06054854

Biobank for the Identification of Biomarkers in Lung Cancer (BIRD, Biomarkers in Respiratory Disease)

Biobank for the Identification of Diagnostic, Prognostic or Therapeutic (Response and Resistance) Biomarkers in Lung Cancer (Early and Advanced Stages of Lung Cancer Cohort of the BIRD (Biomarkers in Respiratory Disease) Biobank)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (estimated)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The BIRD biobank aims at collecting clinical and biological data from patients suffering from a chronic respiratory disease. The lung cancer subpopulation will be divided into two cohorts to identify biomarkers of cancer. One cohort will include patients with supra-centimetric lung nodule(s) whether surveillance, bronchoscopic or radio-guided biopsy or surgery is indicated, patients suspected of lung cancers requiring diagnostic and/or therapeutic bronchial endoscopy and patients with a known early stage lung cancer (early-stage cohort). The second cohort will include known advanced stage lung cancers (III-IV).

Detailed description

Lung cancer is the leading cause of cancer death. In France, lung cancer is a common cancer (fourth cause of cancer) with 49,000 new cases diagnosed each year and nearly 29,000 deaths per year. New therapies (targeted therapies and immune checkpoint inhibitors) are now available and improve patient care. However, their prescription is based on the molecular analysis of the biopsies which are often of very small size, sometimes performed on lesions that are difficult to access, requiring invasive sampling that are difficult to repeat over time. Identifying biomarkers via different fluids that are easier to access (blood, bronchiolo-alveolar lavage, etc.) therefore is strongly needed to improve screening and diagnosis and to optimize treatment. The objectives of this biobank are: To identify diagnostic, theragnostic, prognostic or therapeutic biomarkers in early and advanced stage lung cancer. To evaluate the prevalence of lung cancer and identify predictive biomarkers for malignancy in patients with lung nodule(s). To test the feasibility and diagnostic yield of the detection of known biomarkers in non or less invasive biological specimens (blood, urine, other) and analyse the concordance with tissue biopsy. To identify mechanisms of oncogenesis and identify new molecular targets for anticancer treatment using genomics, transcriptomics or proteomics. After informed consent, clinical data and biological samples will be collected up to 15 years, at the inclusion of the patients in the cohort, and at each monitoring programmed in their usual care. Up to 10 different biological fluids (blood (up to 55 ml), bronchoalveolar lavage, mediastinal node or mass, or peripheral nodule aspiration supernatant, urine, pleural fluid, cerebrospinal fluid, saliva, nasal swamp, stool) will be obtained depending on the case.

Conditions

• Lung Nodule
• Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Extra blood sampling, Non-invasive or leftover samples or medical waste	Extra blood sampling, Urine, Saliva, Stool, Superficial nasal swamp sampling. Bronchoalveolar lavage fluid, Mediastinal node or mass, Peripheral nodule aspiration supernatant, Pleural fluid, Cerebrospinal fluid collection (leftover samples or medical waste). Blood will be collected in larger quantity during a blood test planned as part of the patient's care. Non-invasive or leftover samples or medical waste will be collected on top of the usual diagnosis and during follow-up, depending on the case.

Timeline

• Start date: 2024-06-13
• Primary completion: 2033-10-01
• Completion: 2033-10-01
• First posted: 2023-09-26
• Last updated: 2026-03-19

Locations

1 site across 1 country: France