Evaluation of Calcinosis in Systemic Sclerosis

Systemic Sclerosis Clinical Trial

— CALCIDERMIS  

Official title:

Evaluation of Calcinosis Prevalence in Systemic Sclerosis : a Cross Sectional Study Evaluating Calcinosis Cutis Prevalence by Hand and Feet Radiographic Assessment in Systemic Sclerosis Patients and Study Their Correlation With Organ Injury

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03340194
• Other study ID #: 2016_43
• Secondary ID: 2017-A01822-51
• Status: Active, not recruiting
• Start date: November 30, 2017
• Est. completion date: June 2020

Study information

• Verified date: July 2019
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Calcinosis
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Radiation:
• Radiography
Radiography of the hand and feet (face incident) the day of the inclusion

Procedure:
• Veinous punction
Blood sample to analysis VEGF, endothelin 1, endostatin and P/GF, (ELISA method)

Locations

Country	Name	City	State
France	Hôpital Claude Huriez, CHU	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calcinosis cutis prevalence by radiographic assessment		at inclusion ( baseline)
Secondary	Demographic data		at inclusion ( baseline)
Secondary	Rodnan score		at inclusion ( baseline)
Secondary	Visceral localisation evaluation (cardiac, pulmonary, digestive)		at inclusion ( baseline)
Secondary	EUSTAR score		at inclusion ( baseline)
Secondary	Medsger score		at inclusion ( baseline)
Secondary	Quality of life evaluation (HAQ modified questionary)		at inclusion ( baseline)
Secondary	Biologic vascular markers : VEGF, endothelin 1, endostatin and P/GF, (ELISA method)		at inclusion ( baseline)