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

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Recruiting

CT.gov ID

NCT04751279

Collaborator

(none)

Enrollment

Location

33.8

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sarcoidosis JAK-STAT Pathway Deregulation	Other: Blood sample

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 Design

Study Type:

Observational

Anticipated Enrollment :

80 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 9, 2021

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jan 2, 2024

Arms and Interventions

Arm	Intervention/Treatment
Patients with pulmonary sarcoidosis without signs of chest activity and recent diagnosis (<5 years) Patients with pulmonary sarcoidosis without signs of chest activity (Benamore score <2) and recent diagnosis (<5 years)	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
Patients with pulmonary sarcoidosis with signs of chest activity and recent diagnosis (<5 years Patients with pulmonary sarcoidosis with signs of chest activity (Benamore score ≥2) and recent diagnosis (<5 years)	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
Patients with pulmonary sarcoidosis without signs of activity , persistent form (>5 years) Patients with pulmonary sarcoidosis without signs of activity (Benamore score <2), persistent form (>5 years)	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
Patients with pulmonary sarcoidosis with signs of chest activity , persistent form (>5 years) Patients with pulmonary sarcoidosis with signs of chest activity (Benamore score ≥2), persistent form (>5 years)	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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Service de pneumologie Hôpital Avicenne	Bobigny		France	93000

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator: Florence JENY, MD, Assistance Publique - Hôpitaux Paris

Study Documents (Full-Text)

None provided.

More Information

Publications

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). pii: 1801482. doi: 10.1183/13993003.01482-2018. Print 2018 Dec.

Responsible Party:

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT04751279

Other Study ID Numbers:

APHP201205
2020-A02330-39

First Posted:

Feb 12, 2021

Last Update Posted:

Sep 23, 2021

Last Verified:

Dec 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Assistance Publique - Hôpitaux de Paris

Sarcoidosis

JAK/STAT

Additional relevant MeSH terms:

Sarcoidosis

Granuloma

Study Results

No Results Posted as of Sep 23, 2021