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

NCT ID: NCT04751279

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-09
• Study Completion Date: 2024-01-02

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.

Conditions

Sarcoidosis; JAK-STAT Pathway Deregulation

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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)

Blood sample

Intervention Type: OTHER

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)

Blood sample

Intervention Type: OTHER

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)

Blood sample

Intervention Type: OTHER

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)

Blood sample

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Florence JENY, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux Paris

Locations

Service de pneumologie Hôpital Avicenne

Bobigny, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Florence JENY, MD

Role: CONTACT

florence.jeny@aphp.fr

0148955129

Valerie BESNARD, PhD

Role: CONTACT

valerie.besnard@univ-paris13.fr

Facility Contacts

Florence JENY, DR

Role: primary

florence.jeny@aphp.fr

01 48 95 74 35

Zahia BEN ABDESSELAM, Dr

Role: backup

zahia.ben-abdesselam@aphp.fr

01 48 95 74 35

References

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.

Reference Type: BACKGROUND

PMID: 30361243 (View on PubMed)

Other Identifiers

2020-A02330-39

Identifier Type: OTHER

Identifier Source: secondary_id

APHP201205

Identifier Type: -

Identifier Source: org_study_id