Biobank for the Identification of Biomarkers in Lung Cancer (BIRD, Biomarkers in Respiratory Disease)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Toulouse
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patient with lung nodule or lung cancer
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Extra blood sampling, Non-invasive or leftover samples or medical waste
Biological/VaccineExtra 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.
Treatment groups
3,000 Participants
are divided into 1 treatment groupGroup A: Patients with lung nodule or lung cancer1 intervention
Trial outcomes
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.
Time frame
At the inclusion and up to 15 years after the inclusionSecondary outcomes
1
Identify new biomarkers and/or sets of biomarkers in patients with lung nodules (diagnostic biomarkers) or advanced lung cancer (prognostic or therapeutic biomarkers).
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
Time frame
At the inclusion and up to 15 years after the inclusion2
Explore whether known tumor markers of interest can be found in other biological samples that are easier to access (urine, blood, etc.).
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
Time frame
At the inclusion and up to 15 years after the inclusion3
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.
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
Time frame
At the inclusion and up to 15 years after the inclusion4
Study the evolution over time of the biomarkers of interest and/or newly identified in the biological sample(s) constituting the collection.
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
Time frame
At the inclusion and up to 15 years after the inclusionSponsors and contacts
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Source ClinicalTrials.gov