Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04751279
Recruitment Status : Recruiting
First Posted : February 12, 2021
Last Update Posted : September 23, 2021
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated 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 : March 9, 2021
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : January 2, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sarcoidosis

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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



Biospecimen Retention:   Samples Without DNA
Peripheral blood mononuclear cells

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04751279


Contacts
Layout table for location contacts
Contact: Florence JENY, MD 0148955129 florence.jeny@aphp.fr
Contact: Valerie BESNARD, PhD valerie.besnard@univ-paris13.fr

Locations
Layout table for location information
France
Service de pneumologie Hôpital Avicenne Recruiting
Bobigny, France, 93000
Contact: Florence JENY, DR    01 48 95 74 35    florence.jeny@aphp.fr   
Contact: Zahia BEN ABDESSELAM, Dr    01 48 95 74 35    zahia.ben-abdesselam@aphp.fr   
Principal Investigator: Florence JENY, Dr         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Layout table for investigator information
Principal Investigator: Florence JENY, MD Assistance Publique - Hôpitaux Paris
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04751279    
Other Study ID Numbers: APHP201205
2020-A02330-39 ( Other Identifier: IDRCB )
First Posted: February 12, 2021    Key Record Dates
Last Update Posted: September 23, 2021
Last Verified: December 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Sarcoidosis
JAK/STAT
Additional relevant MeSH terms:
Layout table for MeSH terms
Sarcoidosis
Granuloma
Lymphoproliferative Disorders
Lymphatic Diseases
Pathologic Processes