Lung NoduleBIRD-NKNCT06054854
Biobank for the Identification of Biomarkers in Lung Cancer (BIRD, Biomarkers in Respiratory Disease)
An observational study of Lung Nodule and Lung Cancer, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Nodule, Lung Cancer
- What is being tested?
- Extra blood sampling, Non-invasive or leftover samples or medical waste
- How many people
- 3,000 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jun 2024to 1 Oct 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with lung nodule or lung cancer
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Larrey Hospital
Toulouse, 31059
Nicolas GUIBERT, 567771836 ext. 0033, guibert.n@chu-toulouse.fr
Nicolas GUIBERT
About this study
Official title: 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)
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).
Read the 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
- Being tested
- Extra blood sampling, Non-invasive or leftover samples or medical waste
- Keywords
- Lung Nodule, Lung Cancer, Early Stage Lung Cancer, Advanced Lung Cancer, Liquid Biopsy, Biomarkers
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extra blood sampling, Non-invasive or leftover samples or medical wasteBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with lung nodule or lung cancer | Patients suspected of or suffering from early stage (supracentimetric nodule) or advanced thoracic cancer Receives: Biological: Extra blood sampling, Non-invasive or leftover samples or medical waste |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
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
Measured: 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.).
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
Measured: 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.
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
Measured: 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.
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
Measured: 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.
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
Measured: At the inclusion and up to 15 years after the inclusion
Determine the prevalence of bronchial cancer in patients with supracentimetric lung nodules.
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
Measured: At the inclusion and up to 15 years after the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start13 Jun 2024
- Primary completion1 Oct 2033 (estimated)
- Study completion1 Oct 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NoduleStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas GUIBERT, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06054854
- Sponsor's protocol ID
- RC31/22/0492
- Acronym
- BIRD-NK
- Status last verified
- Mar 2026
- First submitted
- 7 Sep 2023
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06054854
- Acronym / sponsor ID
- BIRD-NK / RC31/22/0492
- Conditions
- Lung Nodule, Lung Cancer
- Keywords
- Lung Nodule, Lung Cancer, Early Stage Lung Cancer, Advanced Lung Cancer, Liquid Biopsy, Biomarkers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 13 Jun 2024 (actual)
- Primary completion
- 1 Oct 2033 (estimated)
- Study completion
- 1 Oct 2033 (estimated)
- First posted
- 26 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with lung nodule or lung cancer | – | Biological: Extra blood sampling, Non-invasive or leftover samples or medical wastePatients suspected of or suffering from early stage (supracentimetric nodule) or advanced thoracic cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with lung nodule or lung cancer
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extra blood sampling, Non-invasive or leftover samples or medical wasteExtra 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. | Biological | Patients with lung nodule or lung cancer |
Primary outcome
Constitution of a clinico-biological collection from patients suspected of or suffering from early stage (supracentimetric nodule) or advanced thoracic cancer.
Time frame: At the inclusion and up to 15 years after the inclusion
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.
6 secondary outcomes
Identify new biomarkers and/or sets of biomarkers in patients with lung nodules (diagnostic biomarkers) or advanced lung cancer (prognostic or therapeutic biomarkers).
Time frame: 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.).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At the inclusion and up to 15 years after the inclusion
Determine the prevalence of bronchial cancer in patients with supracentimetric lung nodules.
Time frame: At the inclusion and up to 15 years after the inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicolas GUIBERT principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Nodule and Lung Cancer, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas GUIBERT, MD PhD (+33567771836, guibert.n@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constitution of a clinico-biological collection from patients suspected of or suffering from early stage (supracentimetric nodule) or advanced thoracic cancer. (time frame: At the inclusion and up to 15 years after the inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.