Mapping and Characterization of Alveolar Cells During Smoking and Chronic Obstructive Disease
CoStemCells
1 other identifier
interventional
186
1 country
4
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2022
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 4, 2021
CompletedFirst Posted
Study publicly available on registry
February 7, 2022
CompletedStudy Start
First participant enrolled
October 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 5, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 5, 2030
September 2, 2025
August 1, 2025
8 years
November 4, 2021
August 26, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Number of alveolar organoids
Comparison of the number of alveolar organoids formed 21 days after culture of fibroblasts with alveolar type II cells between smokers with and without COPD and non-smoking patients
through study completion, an average of 3 years
Secondary Outcomes (17)
Fibroblast proliferation capacity
through study completion, an average of 3 years
Differentiation into myofibroblasts
through study completion, an average of 3 years
Fibroblast migration capacity
through study completion, an average of 3 years
Modulated signaling pathways in isolated fibroblasts between groups
through study completion, an average of 3 years
Modulated signaling pathways in endothelial cells between groups
through study completion, an average of 3 years
- +12 more secondary outcomes
Study Arms (1)
Thoracic resection surgery
OTHERSmokers (active or ex-smokers) and non-smokers with COPD and without COPD undergoing thoracic resection surgery
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Rousseau-Bussac
Créteil, 94000, France
Hopital Cochin
Paris, 75014, France
HEGP
Paris, 75015, France
Hopital Tenon
Paris, 75020, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2021
First Posted
February 7, 2022
Study Start
October 5, 2022
Primary Completion (Estimated)
October 5, 2030
Study Completion (Estimated)
October 5, 2030
Last Updated
September 2, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share