Ignite Creation Date:
2024-05-06 @ 7:33 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06054854
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-29
First Post:
2023-09-07
Brief Title:
Biobank for the Identification of Biomarkers in Lung Cancer BIRD Biomarkers in Respiratory Disease
Sponsor:
University Hospital Toulouse
Organization:
University Hospital Toulouse
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIRD-NK
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 nodules whether surveillance bronchoscopic or radio-guided biopsy or surgery is indicated patients suspected of lung cancers requiring diagnostic andor 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 49000 new cases diagnosed each year and nearly 29000 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 nodules
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
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 nodules
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None