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

NCT04751279 | Unknown

• 2 other identifiers: APHP2012052020-A02330-39
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcoidosis; JAK-STAT Pathway Deregulation

Keywords

Sarcoidosis; JAK/STAT

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

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

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

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

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

Interventions

Blood sample 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 and recent diagnosis (<5 years; Patients with pulmonary sarcoidosis without signs of activity , persistent form (>5 years); Patients with pulmonary sarcoidosis without signs of chest activity and recent diagnosis (<5 years)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with mediastino-pulmonary sarcoidosis receiving or not receiving treatment for their sarcoidosis. Subjects treated for their sarcoidosis (corticosteroids and/or immunosuppressants) are not excluded because of two recent cases reported of multi-treated patients in which an involvement of the JAK/STAT pathway was demonstrated.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service de pneumologie Hôpital Avicenne

Bobigny, 93000, France

RECRUITING

Related 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.

  PMID: 30361243 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood mononuclear cells

MeSH Terms

Conditions

Sarcoidosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Florence JENY, MD

  Assistance Publique - Hôpitaux Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Florence JENY, MD

CONTACT

0148955129; florence.jeny@aphp.fr

Valerie BESNARD, PhD

CONTACT

valerie.besnard@univ-paris13.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 12, 2021
• Study Start: March 9, 2021
• Primary Completion: January 1, 2024
• Study Completion: January 2, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

FR (1)