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

Sarcoidosis Clinical Trial

— JAK-SARC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04751279
• Other study ID #: APHP201205
• Secondary ID: 2020-A02330-39
• Status: Recruiting
• Start date: March 9, 2021
• Est. completion date: January 2, 2024

Study information

• Verified date: November 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Florence JENY, MD
• Phone: 0148955129
• Email: florence.jeny[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 2, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Granuloma
• JAK-STAT Pathway Deregulation
• Sarcoidosis

Intervention

Other:
• Blood sample
Blood sample collection of 5 blood sample at the inclusion in the study the samle consite of 5 tubesEthylene Diamine Tetra Acetate (ADTA) of 7 ml

Locations

Country	Name	City	State
France	Service de pneumologie Hôpital Avicenne	Bobigny

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

Rotenberg C, Besnard V, Brillet PY, Giraudier S, Nunes H, Valeyre D. Dramatic response of refractory sarcoidosis under ruxolitinib in a patient with associated JAK2-mutated polycythemia. Eur Respir J. 2018 Dec 20;52(6):1801482. doi: 10.1183/13993003.01482-2018. Print 2018 Dec. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	JAK/STAT familly numbers protein expression in PBMCs	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	1 year after inclusion