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

NCT ID: NCT06054854

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 3000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-13
• Study Completion Date: 2033-10-01

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with lung nodule or lung cancer

Patients suspected of or suffering from early stage (supracentimetric nodule) or advanced thoracic cancer

Extra blood sampling, Non-invasive or leftover samples or medical waste

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Patients with 1 to 3 lung nodules including one > 1 cm seen on chest CT
• OR: patients with suspected lung cancer requiring diagnostic and/or therapeutic bronchial endoscopy
• OR: Patient with histologically confirmed lung cancer, whether early stages prior to surgery, locally advanced or metastatic, included before the start of any anti-cancer treatment.
• Patient affiliated or beneficiary of a social security scheme
• Patients who are able to receive and understand information about the study and their participation and who have freely given their signed inform consent before any collection of samples or data necessary for the research (no restriction of rights by the judicial authorities and knowledge of the French language).

Exclusion Criteria

• Patient deprived of liberty on administrative or judicial decision, or patient under guardianship, curators or safeguard of justice
• Female patients who are pregnant or breastfeeding

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicolas GUIBERT

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

Larrey Hospital

Toulouse, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Nicolas GUIBERT, MD PhD

Role: CONTACT

guibert.n@chu-toulouse.fr

+33567771836

Facility Contacts

Nicolas GUIBERT

Role: primary

guibert.n@chu-toulouse.fr

567771836 ext. 0033

Other Identifiers

RC31/22/0492

Identifier Type: -

Identifier Source: org_study_id