NCT05227547

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
186

participants targeted

Target at P75+ for not_applicable

Timeline
53mo left

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress45%
Oct 2022Oct 2030

First Submitted

Initial submission to the registry

November 4, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 7, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

October 5, 2022

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2030

Last Updated

September 2, 2025

Status Verified

August 1, 2025

Enrollment Period

8 years

First QC Date

November 4, 2021

Last Update Submit

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

OTHER

Smokers (active or ex-smokers) and non-smokers with COPD and without COPD undergoing thoracic resection surgery

Other: 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.

Thoracic resection surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

Hopital Cochin

Paris, 75014, France

ACTIVE NOT RECRUITING

HEGP

Paris, 75015, France

ACTIVE NOT RECRUITING

Hopital Tenon

Paris, 75020, France

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

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

Locations