Evaluation of Calcinosis in Systemic Sclerosis

• Conditions: Systemic Sclerosis
• Interventions: Radiation: Radiography; Procedure: Veinous punction

• Registration Number: NCT03340194
• Lead Sponsor: University Hospital, Lille

Brief Summary

Systemic sclerosis is a rare pathology characterized by fibrosis and vascular lesion with skin, pulmonary, digestive and cardiac localisation. Calcinosis cutis is commonly described, but its prevalence and appear few documented in literature. Moreover, this studies used clinical observation to determine presence or absence of calcification, and rarely radiography, in particular for feet localisation. In the same way, skin calcification and organ injury association appear unclear. The aim of the study is firstly to determine prevalence of calcinosis cutis, with hand and feet radiography realisation in a cohort of systemic sclerosis patient. Secondly, will be determine the correlation between calcinosis and organ injury.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-08
• Study First Submitted QC: 2017-11-08
• Study First Posted: 2017-11-13
• Study Start: 2017-11-30
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-10
• Last Update Posted: 2019-07-11
• Primary Completion: 2020-06
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Systemic sclerosis presenting ACR-EULAR 2013 criteria
• Given their consent
• Titulary of health insurance

Exclusion Criteria

• Dermatomyositis overlap
• Pregnant or breastfeeding women
• Imprisoned person
• Refuse of consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Systemic sclerosis patients	Radiography	-
Systemic sclerosis patients	Veinous punction	-

Primary Outcome Measures

Name	Time	Method
Calcinosis cutis prevalence by radiographic assessment	at inclusion ( baseline)

Secondary Outcome Measures

Name	Time	Method
Visceral localisation evaluation (cardiac, pulmonary, digestive)	at inclusion ( baseline)
EUSTAR score	at inclusion ( baseline)
Medsger score	at inclusion ( baseline)
Quality of life evaluation (HAQ modified questionary)	at inclusion ( baseline)
Demographic data	at inclusion ( baseline)
Rodnan score	at inclusion ( baseline)
Biologic vascular markers : VEGF, endothelin 1, endostatin and P/GF, (ELISA method)	at inclusion ( baseline)

Trial Locations

Locations (1)

Hôpital Claude Huriez, CHU; 🇫🇷 Lille, France