## Protocol Section
### Identification Module
**NCT ID:** NCT06412614

**Acronym:** SCLERONAB

**Brief Title:** Evaluation of Patients With Systemic Sclerosis Without Specific or Associated Autoantibodies

**Official Title:** Phenotypic Evaluation of Patients With Systemic Sclerosis Without Specific or Associated Autoantibodies

#### Organization Study ID Info
**ID:** 2024PI015
#### Organization
**Class:** OTHER
**Full Name:** Central Hospital, Nancy, France
### Status Module
#### Completion Date
**Date:** 2025-06-29

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-08

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-06-29

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-09-02

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-06
**Study First Submit QC Date:** 2024-05-08
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Central Hospital, Nancy, France

#### Responsible Party

**Investigator Affiliation:** Central Hospital, Nancy, France

**Investigator Full Name:** Paul DECKER, MD

**Investigator Title:** Principal investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Systemic sclerosis (SSc) is a complex systemic autoimmune disease with variable phenotype and prognosis. Autoantibodies are important diagnostic biomarkers in SSc. More than 90% of patients with SSc had anti-nuclear antibodies. Autoantibodies specific to SSc (anti-topoisomerase I antibodies, anti-centromeres, anti-RNA polymerase III, anti-Th/To, anti-fibrillarin, anti-NOR90) or associated with overlap syndromes (anti-RNA polymerase III antibodies -PM/Scl, anti-KU, anti-U1RNP, anti-TRIM21) are detected in most patients. Excluding anti-TRIM21 antibodies, autoantibodies are usually mutually exclusive and are associated with distinct phenotypes.

Around 5 to 10% of patients with SSc have no autoantibodies detectable with routine biological tests. Recently, new autoantibody specificities have been described in SSc (anti-eIF2B, anti-RuvBL1/2, anti-BICD2, anti-U11/U12 RNP antibodies).

"Seronegative" patients could represent new specificities of autoantibodies (unknown or not currently routinely evaluated) associated with different phenotypes of the disease.

Primary objective is to compare the phenotype of patients with systemic sclerosis with or without detectable specific or associated autoantibodies.

Secondary objectives are:

* to determine homogeneous groups of patients with systemic sclerosis without detectable specific or associated autoantibodies
* to compare the phenotype of patients with systemic sclerosis without detectable specific or associated autoantibodies according to anti-nuclear antibodies status

### Conditions Module

**Conditions:**

- Systemic Sclerosis

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 300

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Other: disease phenotype

**Label:** SSc patients without specific or associated autoantibodies ("seronegative" patients)

#### Arm Group 2

**Intervention Names:**

- Other: disease phenotype

**Label:** SSc patients with specific or associated autoantibodies

### Interventions

#### Intervention 1

**Arm Group Labels:**

- SSc patients with specific or associated autoantibodies

- SSc patients without specific or associated autoantibodies ("seronegative" patients)

**Description:** evaluation of SSc phenotypes

**Name:** disease phenotype

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** duration between date of first symptom (excluding Raynaud's phenomenon) and SSc diagnosis

**Measure:** diagnosis time

**Time Frame:** baseline (J0)

#### Secondary Outcomes

**Description:** sine scleroderma (no scleroderma), limited scleroderma or diffuse scleroderma

**Measure:** number of patients with scleroderma

**Time Frame:** baseline (J0)

**Measure:** number of patients with raynaud's phenomenon

**Time Frame:** baseline (J0)

**Measure:** number of patients with digital ulcers

**Time Frame:** baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)

**Measure:** number of patients with calcinosis

**Time Frame:** baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)

**Measure:** number of patients with telangiectases

**Time Frame:** baseline (J0)

**Measure:** number of patients with articular involvement

**Time Frame:** baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)

**Measure:** number of patients with muscular involvement

**Time Frame:** baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)

**Measure:** number of patients with cardiac involvement

**Time Frame:** baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)

**Measure:** number of patients with interstitial lung disease

**Time Frame:** baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)

**Measure:** number of patients with pulmonary arterial hypertension

**Time Frame:** baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)

**Measure:** number of patients with scleroderma renal crisis

**Time Frame:** baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)

**Measure:** number of patients with gastrointestinal involvement

**Time Frame:** baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)

**Measure:** modified Rodnan skin score

**Time Frame:** baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)

**Description:** %predicted FVC values

**Measure:** forced vital capacity (FVC)

**Time Frame:** baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)

**Description:** %predicted DLCO values

**Measure:** diffusing capacity for carbon monoxide (DLCO)

**Time Frame:** baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)

**Measure:** rate of patients without death

**Time Frame:** 3 years and 5 years of follow-up

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patient with systemic sclerosis defined according to ACR/EULAR 2013 classification criteria
* Patient with a minimum follow-up of 3 years since the diagnosis of systemic sclerosis
* Patient evaluated for the following systemic sclerosis specific and/or associated autoantibodies: anti-topoisomerase I, anti-centromere, anti-RNA polymerase III (RP155 and RP11), anti-Th/To antibodies , anti-fibrillarin, anti-NOR90, anti-PM/Scl, anti-KU, anti-U1RNP and anti-SSA antibodies (independently of antinuclear antibodies status)

Exclusion Criteria:

* Patient with equivocal results for one or more systemic sclerosis specific and/or associated autoantibodies
* Patient initially negative but with a positive result for systemic sclerosis specific and/or associated autoantibodies during follow-up

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients followed in internal medicine or rheumatology units until December 2021

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** p.decker@chru-nancy.fr

**Name:** Paul Decker, MD

**Phone:** +33383157240

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Angers

**Contacts:**

***Contact 1:***

- **Name:** Christian Lavigne

- **Role:** CONTACT

**Country:** France

**Facility:** CHU Angers

**Location 2:**

**City:** Brest

**Contacts:**

***Contact 1:***

- **Name:** Claire De Moreuil

- **Role:** CONTACT

**Country:** France

**Facility:** CHU Brest

**Location 3:**

**City:** Dunkerque

**Contacts:**

***Contact 1:***

- **Name:** Amélie Leurs

- **Role:** CONTACT

**Country:** France

**Facility:** CH Dunkerque

**Location 4:**

**City:** Grenoble

**Contacts:**

***Contact 1:***

- **Name:** Alban Deroux

- **Role:** CONTACT

**Country:** France

**Facility:** CHU Grenoble

**Location 5:**

**City:** Lille

**Contacts:**

***Contact 1:***

- **Name:** David Launay

- **Role:** CONTACT

**Country:** France

**Facility:** CHU Lille

**Location 6:**

**City:** Lyon

**Contacts:**

***Contact 1:***

- **Name:** Claire Grange

- **Role:** CONTACT

**Country:** France

**Facility:** Hospices Civils de Lyon

**Location 7:**

**City:** Marseille

**Contacts:**

***Contact 1:***

- **Name:** Brigitte Granel

- **Role:** CONTACT

**Country:** France

**Facility:** AP-HM

**Location 8:**

**City:** Nice

**Contacts:**

***Contact 1:***

- **Name:** Viviane Queyrel

- **Role:** CONTACT

**Country:** France

**Facility:** CHU Nice

**Location 9:**

**City:** Paris

**Contacts:**

***Contact 1:***

- **Name:** Benjamin Chaigne

- **Role:** CONTACT

**Country:** France

**Facility:** APHP

**Location 10:**

**City:** Poitiers

**Contacts:**

***Contact 1:***

- **Name:** Mickaël Martin

- **Role:** CONTACT

**Country:** France

**Facility:** CHU Poitiers

**Location 11:**

**City:** Reims

**Contacts:**

***Contact 1:***

- **Name:** Amélie Servettaz

- **Role:** CONTACT

**Country:** France

**Facility:** CHU Reims

**Location 12:**

**City:** Rennes

**Contacts:**

***Contact 1:***

- **Name:** Alain Lescoat

- **Role:** CONTACT

**Country:** France

**Facility:** CHU Rennes

**Location 13:**

**City:** Strasbourg

**Country:** France

**Facility:** Hôpitaux Universitaires de Strasbourg

**Location 14:**

**City:** Strasbourg

**Contacts:**

***Contact 1:***

- **Name:** Emmanuel Chatelus

- **Role:** CONTACT

**Country:** France

**Facility:** Hôpitaux Universitaires de Strasbourg

### IPD Sharing Statement Module

**IPD Sharing:** NO

## 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: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M15415

- Name: Sclerosis

- Relevance: HIGH

- As Found: Sclerosis

- 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

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4625

- Name: Autoantibodies

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
