## Protocol Section
### Identification Module
**NCT ID:** NCT04751279

**Acronym:** JAK-SARC

**Brief Title:** Expression and Role of the JAK/STAT Pathway in Sarcoidosis Granuloma Cells

**Official Title:** Expression and Role of the JAK/STAT Pathway in Sarcoidosis Granuloma Cells

#### Organization Study ID Info
**ID:** APHP201205
#### Organization
**Class:** OTHER
**Full Name:** Assistance Publique - Hôpitaux de Paris
#### Secondary ID Infos
**Domain:** IDRCB
**ID:** 2020-A02330-39
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2024-01-02

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-11-18

**Type:** ACTUAL

**Last Update Submit Date:** 2023-11-15

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-01-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-03-09

**Type:** ACTUAL

**Status Verified Date:** 2023-11

#### Study First Post Date
**Date:** 2021-02-12
**Type:** ACTUAL
**Study First Submit Date:** 2021-01-29
**Study First Submit QC Date:** 2021-02-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Assistance Publique - Hôpitaux de Paris

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Sarcoidosis

- JAK-STAT Pathway Deregulation

**Keywords:**

- Sarcoidosis

- JAK/STAT

### Design Module

#### Bio Spec

**Description:** Peripheral blood mononuclear cells

**Retention:** SAMPLES_WITHOUT_DNA

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 80

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients with pulmonary sarcoidosis without signs of chest activity (Benamore score \<2) and recent diagnosis (\<5 years)

**Intervention Names:**

- Other: Blood sample

**Label:** Patients with pulmonary sarcoidosis without signs of chest activity and recent diagnosis (<5 years)

#### Arm Group 2

**Description:** Patients with pulmonary sarcoidosis with signs of chest activity (Benamore score ≥2) and recent diagnosis (\<5 years)

**Intervention Names:**

- Other: Blood sample

**Label:** Patients with pulmonary sarcoidosis with signs of chest activity and recent diagnosis (<5 years

#### Arm Group 3

**Description:** Patients with pulmonary sarcoidosis without signs of activity (Benamore score \<2), persistent form (\>5 years)

**Intervention Names:**

- Other: Blood sample

**Label:** Patients with pulmonary sarcoidosis without signs of activity , persistent form (>5 years)

#### Arm Group 4

**Description:** Patients with pulmonary sarcoidosis with signs of chest activity (Benamore score ≥2), persistent form (\>5 years)

**Intervention Names:**

- Other: Blood sample

**Label:** Patients with pulmonary sarcoidosis with signs of chest activity , persistent form (>5 years)

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 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)

**Description:** 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

**Name:** Blood sample

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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

**Measure:** JAK/STAT familly numbers protein expression in PBMCs

**Time Frame:** 1 year after inclusion

### Eligibility Module

**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.

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** florence.jeny@aphp.fr

**Name:** Florence JENY, MD

**Phone:** 0148955129

**Role:** CONTACT

**Contact 2:**

**Email:** valerie.besnard@univ-paris13.fr

**Name:** Valerie BESNARD, PhD

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Bobigny

**Contacts:**

***Contact 1:***

- **Email:** florence.jeny@aphp.fr

- **Name:** Florence JENY, DR

- **Phone:** 01 48 95 74 35

- **Role:** CONTACT

***Contact 2:***

- **Email:** zahia.ben-abdesselam@aphp.fr

- **Name:** Zahia BEN ABDESSELAM, Dr

- **Phone:** 01 48 95 74 35

- **Role:** CONTACT

***Contact 3:***

- **Name:** Florence JENY, Dr

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** France

**Facility:** Service de pneumologie Hôpital Avicenne

**Status:** RECRUITING

**Zip:** 93000

#### Overall Officials

**Official 1:**

**Affiliation:** Assistance Publique - Hôpitaux Paris

**Name:** Florence JENY, MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** 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

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000008232

- Term: Lymphoproliferative Disorders

- ID: D000008206

- Term: Lymphatic Diseases

- ID: D000006968

- Term: Hypersensitivity, Delayed

- ID: D000006967

- Term: Hypersensitivity

- ID: D000007154

- Term: Immune System Diseases

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M15325

- Name: Sarcoidosis

- Relevance: HIGH

- As Found: Sarcoidosis

- ID: M9202

- Name: Granuloma

- Relevance: HIGH

- As Found: Granuloma

- ID: M11225

- Name: Lymphoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M11203

- Name: Lymphatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10018

- Name: Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M10019

- Name: Hypersensitivity, Delayed

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012507

- Term: Sarcoidosis

- ID: D000006099

- Term: Granuloma

### Misc Info Module

- Version Holder: 2024-05-24
