Expression and Role of the JAK/STAT Pathway in Sarcoidosis Granuloma Cells

Recruiting

• Conditions: Sarcoidosis; JAK-STAT Pathway Deregulation
• Interventions: Other: Blood sample

• Registration Number: NCT04751279
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

Recent studies suggest that the JAK/STAT signaling pathway constitutes a new step in the clinical and therapeutic progress of sarcoidosis. Further investigations are necessary to identify the most suitable patients to receive treatment targeting this pathway, in particular in cases of severe sarcoidosis refractory to the various therapeutic lines.

Detailed Description

The investigators hypothesize that the JAK/STAT signaling pathway constitutes a new step in the clinical and therapeutic progress of sarcoidosis, in particular in cases of severe sarcoidosis refractory to the various therapeutic lines. The main objective of this proposal is to evaluate the presence and stage of activation of the JAK/STAT pathway in PBMCs from inactive and active sarcoidosis patients. The second objective will be to determine the role of the JAK/STAT pathway in the formation and maintenance of granulomas and their association with the severity of sarcoidosis and fibrogenesis.

Study Timeline

• Study First Submitted: 2021-01-29
• Study First Submitted QC: 2021-02-10
• Study First Posted: 2021-02-12
• Study Start: 2021-03-09
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patients with a diagnosis of mediastinopulmonary sarcoidosis made according to ATS / ERS / WASOG criteria
• Or patient suspected of having mediastino-pulmonary sarcoidosis, without any other probable causal factor identified on the usual standard examination at the time of the sample with the need for diagnostic confirmation at the end of the study according to the criteria of the ATS / ERS / WASOG
• Sarcoidosis with stage 1 to 4 pulmonary involvement
• Patients who had a chest CT scan in the 6 months preceding the sample. Examination carried out as part of routine care

Exclusion Criteria

• Pregnancy.
• Opposition expressed to participation in the study.
• Patients on State Medical Aid.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with pulmonary sarcoidosis without signs of activity , persistent form (>5 years)	Blood sample	Patients with pulmonary sarcoidosis without signs of activity (Benamore score \<2), persistent form (\>5 years)
Patients with pulmonary sarcoidosis with signs of chest activity , persistent form (>5 years)	Blood sample	Patients with pulmonary sarcoidosis with signs of chest activity (Benamore score ≥2), persistent form (\>5 years)
Patients with pulmonary sarcoidosis with signs of chest activity and recent diagnosis (<5 years	Blood sample	Patients with pulmonary sarcoidosis with signs of chest activity (Benamore score ≥2) and recent diagnosis (\<5 years)
Patients with pulmonary sarcoidosis without signs of chest activity and recent diagnosis (<5 years)	Blood sample	Patients with pulmonary sarcoidosis without signs of chest activity (Benamore score \<2) and recent diagnosis (\<5 years)

Primary Outcome Measures

Name	Time	Method
JAK/STAT familly numbers protein expression in PBMCs	1 year after inclusion	Evaluation will be carried out by: - studying the expression of members of the JAK/STAT pathway, the expression of cytokines and chemokines phagocytosis and macrophage differentiation the expression of cytokines and chemokines

Trial Locations

Locations (1)

Service de pneumologie Hôpital Avicenne; 🇫🇷 Bobigny, France