Mapping and Characterization of Alveolar Cells During Smoking and Chronic Obstructive Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Thoracic resection surgery.
- Who it may be relevant to
- Registry conditions: Chronic Obstructive Lung Disease, Chronic Obstructive Pulmonary Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
To evaluate the regenerative capacities of mesenchymal cells composing the microenvironment of alveolar type 2 cells in a population of patients, undergoing thoracic surgery for suspected cancer, who are smokers with and without COPD compared to non-smokers patients
Detailed description
Chronic obstructive pulmonary diseases (COPD) have a major public health impact, as evidenced by the 250 million patients affected by these diseases and the 50% 5-year mortality for severe stages of chronic obstructive pulmonary disease (COPD). One pathophysiological mechanism of COPD and emphysema is a depletion of alveolar progenitor cells inducing a loss of alveolar-reparation capacities after an aggression. The genesis of these alterations and the mechanisms involved remain unknown. Alveolar type 2 cells (AT2) are the alveolar epithelial progenitor cells. AT2 proliferate and differentiate into alveolar type 1 cells (AT1) which form the alveolar-capillary barrier, along with endothelial cells, through which respiratory gas exchanges take place. The proliferation and differentiation of AT2 into AT1 are under the control of mesenchymal cells and endothelial cells located in close proximity. Together these cells form the alveolar stem cell niche. The characteristics and interactions of the different cell populations have been well described during lung growth, in the normal adult lung or during pulmonary fibrosis; however, participants are poorly described during smoking exposure and chronic obstructive diseases.
Interventions
- Other Thoracic resection surgery
Patients undergoing thoracic resection surgery (pneumonectomy, lobectomy, segmentectomy) for cancer or suspected cancer, including smokers (active or ex-smokers) and non-smokers, with COPD and without COPD, and non-smoking patients.
Primary outcome measures
- Number of alveolar organoids [Time frame: through study completion, an average of 3 years]
Secondary outcome measures (12)
- Fibroblast proliferation capacity [Time frame: through study completion, an average of 3 years]
- Differentiation into myofibroblasts [Time frame: through study completion, an average of 3 years]
- Fibroblast migration capacity [Time frame: through study completion, an average of 3 years]
- Modulated signaling pathways in isolated fibroblasts between groups [Time frame: through study completion, an average of 3 years]
- Modulated signaling pathways in endothelial cells between groups [Time frame: through study completion, an average of 3 years]
- Evaluation of cytokines in fibroblasts supernatant [Time frame: through study completion, an average of 3 years]
- Tumor progression [Time frame: through study completion, an average of 3 years]
- Identification of different cell types on total lung [Time frame: through study completion, an average of 3 years]
- Severity of pulmonary emphysema, [Time frame: At inclusion, every year, up to 5 years after surgery]
- Type of pulmonary emphysema [Time frame: At inclusion, every year, up to 5 years after surgery]
- Research of pulmonary biomarkers [Time frame: through study completion, an average of 3 years]
- Identification of biomarkers in the pre and postoperative circulating blood [Time frame: through study completion, an average of 3 years]
Eligibility criteria
Inclusion criteria
- Age ≥ 18
- Patient undergoing lung resection surgery (lobectomy, pneumonectomy, segmentectomy) for cancer or suspected cancer
- Acceptance to participate in the protocol
- Affiliated to a social security plan
Exclusion criteria
- Chronic autoimmune disease
- Patient under guardianship or curators
- Neo-adjuvant chemotherapy
- History of thoracic radiotherapy
- Pregnant woman
- Minor patient
- Person not able to consent
- Person deprived of liberty
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 4 centers
- Rousseau-Bussac — Créteil
- Hopital Cochin — Paris
- HEGP — Paris
- Hopital Tenon — Paris
Identifiers
NCT: NCT05227547 · CoStemCells