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

November 15, 2023 updated by: Assistance Publique - Hôpitaux de Paris
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bobigny, France, 93000
        • Recruiting
        • Service de pneumologie Hôpital Avicenne
        • Contact:
        • Contact:
        • Principal Investigator:
          • Florence JENY, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
JAK/STAT familly numbers protein expression in PBMCs
Time Frame: 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
1 year after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Florence JENY, MD, Assistance Publique - Hopitaux Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2021

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

January 2, 2024

Study Registration Dates

First Submitted

January 29, 2021

First Submitted That Met QC Criteria

February 10, 2021

First Posted (Actual)

February 12, 2021

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP201205
  • 2020-A02330-39 (Other Identifier: IDRCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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