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

NCT06054854 | Recruiting

• 1 other identifier: RC31/22/0492
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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).

Conditions

Lung Nodule; Lung Cancer

Keywords

Lung Nodule; Lung Cancer; Early Stage Lung Cancer; Advanced Lung Cancer; Liquid Biopsy; Biomarkers

Outcome Measures

Primary Outcomes (1)

• Constitution of a clinico-biological collection from patients suspected of or suffering from early stage (supracentimetric nodule) or advanced thoracic cancer.

  Extra sample of blood and up to 9 different biological fluids (Urine, Saliva, Stool, Superficial nasal swamp, Bronchoalveolar lavage fluid, Mediastinal node or mass, Peripheral nodule aspiration supernatant, Pleural fluid, Cerebrospinal fluid) will be collected.

  At the inclusion and up to 15 years after the inclusion

Secondary Outcomes (6)

• Identify new biomarkers and/or sets of biomarkers in patients with lung nodules (diagnostic biomarkers) or advanced lung cancer (prognostic or therapeutic biomarkers).

  At the inclusion and up to 15 years after the inclusion

• Explore whether known tumor markers of interest can be found in other biological samples that are easier to access (urine, blood, etc.).

  At the inclusion and up to 15 years after the inclusion

• Estimate the concordance of the presence of known and/or newly identified biomarkers of interest in the biological sample(s) of the collection with the tissue biopsy data.

  At the inclusion and up to 15 years after the inclusion

• Study the evolution over time of the biomarkers of interest and/or newly identified in the biological sample(s) constituting the collection.

  At the inclusion and up to 15 years after the inclusion

• Explore through molecular and/or genomic and/or transcriptomic and/or proteomic studies the biological mechanisms underlying the development of thoracic cancer to improve screening, diagnosis, therapeutic orientation.

  At the inclusion and up to 15 years after the inclusion

Study Arms (1)

Patients with lung nodule or lung cancer

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

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

Interventions

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

Patients with lung nodule or lung cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with lung nodule or lung cancer

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Larrey Hospital

Toulouse, 31059, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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).

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Medical Waste

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Waste Products; Complex Mixtures; Environmental Pollution; Public Health; Environment and Public Health

Study Officials

• Nicolas GUIBERT

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas GUIBERT, MD PhD

CONTACT

+33567771836; guibert.n@chu-toulouse.fr

Study Design

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

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: September 26, 2023
• Study Start: June 13, 2024
• Primary Completion (Estimated): October 1, 2033
• Study Completion (Estimated): October 1, 2033
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

FR (1)