## Protocol Section
### Identification Module
**NCT ID:** NCT02562079

**Acronym:** VISS

**Brief Title:** Vasculopathy, Inflammation and Systemic Sclerosis

**Official Title:** Vasculopathy, Inflammation and Systemic Sclerosis: The Role of Endothelial Cell Activation and OX40/OX40L in Modulation of T Lymphocyte Activation

#### Organization Study ID Info
**ID:** CHUBX 2011/37
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Bordeaux
### Status Module
#### Completion Date
**Date:** 2016-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-04-07

**Type:** ACTUAL

**Last Update Submit Date:** 2017-04-05

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2016-12

**Type:** ACTUAL

#### Start Date
**Date:** 2012-03

**Type:** ACTUAL

**Status Verified Date:** 2017-04

#### Study First Post Date
**Date:** 2015-09-29
**Type:** ESTIMATED
**Study First Submit Date:** 2014-12-29
**Study First Submit QC Date:** 2015-09-25
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Societe Francaise de Rhumatologie

#### Lead Sponsor

**Class:** OTHER

**Name:** University Hospital, Bordeaux

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** It is a study of basic research with mechanistically objectives and including clinical biological samples.

**Detailed Description:** Systemic sclerosis (SSc) is a rare and severe disease characterised by a fibrotic process and an incompletely elucidate physiopathology. Several shared featured have been identified between SSc and another autoimmune disease, the systemic lupus erythematous (SLE) as an interferon-alpha signature, the role of platelets and the polymorphism of OX40 ligand (OX40L). In SLE, OX40L has been shown highly linked to the active form of the disease, was increased by the CD40L of platelets and induced the CD8 cytotoxicity while inhibiting the suppressive functions of regulator T lymphocytes. The third main factor of the SSc physiopathology apart from autoimmunity and fibrosis is the vasculopathy with an important role of endothelial cells (EC). They turned out to be half-professional antigen presenting cells and can modulate the adaptive immunity.

### Conditions Module

**Conditions:**

- Systemic Sclerosis

**Keywords:**

- T lymphocyte

- OX40/OX40L

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 350

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Biological: Blood samples

- Biological: Biopsy

**Label:** subjects SSc diagnosed

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Biological: Blood samples

- Biological: Biopsy

**Label:** subjects Localised sclerosis diagnosed

**Type:** EXPERIMENTAL

#### Arm Group 3

**Intervention Names:**

- Biological: Blood samples

**Label:** subjects Sc

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- subjects Localised sclerosis diagnosed

- subjects SSc diagnosed

- subjects Sc

**Description:** * biological features of the standard follow-up
* 2 more blood tube for the biological collection (serum and PBMC)

**Name:** Blood samples

**Type:** BIOLOGICAL

#### Intervention 2

**Arm Group Labels:**

- subjects Localised sclerosis diagnosed

- subjects SSc diagnosed

**Description:** Skin biopsies

**Name:** Biopsy

**Type:** BIOLOGICAL

### Outcomes Module

#### Primary Outcomes

**Measure:** Assessment of OX40L expression in endothelial cells and skin biopsies.

**Time Frame:** Day 1

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Age from 18 to 75.
* SSc diagnosed according to the American College of Rheumatology (ACR) criteria.
* With skin manifestations since less than 10 years.
* Localised sclerosis (LSc) diagnosed, morphea type.

Exclusion Criteria:

* Age inferior to 18 or upper than 75.
* Skin manifestations since more than 10 years.
* Haemostasis diseases (independent from treatments).
* Stem cell transplant.
* Immunosuppressive treatments in the last 6 months.
* Associate autoimmune disease.

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Bordeaux

**Country:** France

**Facility:** Service de Rhumatologie - Tripode - Hôpital Pellegrin

**Zip:** 33076

#### Overall Officials

**Official 1:**

**Affiliation:** University Hospital Bordeaux, France

**Name:** Marie-Elise TRUCHETET, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000003240

- Term: Connective Tissue Diseases

- ID: D000012871

- Term: Skin Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10293

- Name: Inflammation

- Relevance: HIGH

- As Found: Inflammation

- ID: M15415

- Name: Sclerosis

- Relevance: HIGH

- As Found: Sclerosis

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15412

- Name: Scleroderma, Systemic

- Relevance: HIGH

- As Found: Systemic Sclerosis

- ID: M25560

- Name: Scleroderma, Diffuse

- Relevance: HIGH

- As Found: Systemic Sclerosis

- ID: M6464

- Name: Connective Tissue Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T5565

- Name: Systemic Scleroderma

- Relevance: HIGH

- As Found: Systemic Sclerosis

### Condition Browse Module - Meshes

- ID: D000012595

- Term: Scleroderma, Systemic

- ID: D000045743

- Term: Scleroderma, Diffuse

- ID: D000012598

- Term: Sclerosis

- ID: D000007249

- Term: Inflammation

### Misc Info Module

- Version Holder: 2024-05-24
