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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Constitution of a clinico-biological collection from patients suspected of or suffering from early stage (supracentimetric nodule) or advanced thoracic cancer.
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
Patients with lung nodule or lung cancer
Patients suspected of or suffering from early stage (supracentimetric nodule) or advanced thoracic cancer
干预措施: Extra blood sampling, Non-invasive or leftover samples or medical waste (Biological)
结局指标
主要结局
Constitution of a clinico-biological collection from patients suspected of or suffering from early stage (supracentimetric nodule) or advanced thoracic cancer.
时间窗: 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.
次要结局
- 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)
- 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)
- Determine the prevalence of bronchial cancer in patients with supracentimetric lung nodules.(At the inclusion and up to 15 years after the inclusion)
- 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)
- 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)
- 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)