Evaluation of Calcinosis in Systemic Sclerosis
CALCIDERMIS
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
2 other identifiers
observational
214
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 8, 2017
CompletedFirst Posted
Study publicly available on registry
November 13, 2017
CompletedStudy Start
First participant enrolled
November 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 14, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 2, 2021
CompletedDecember 5, 2025
December 1, 2025
1.5 years
November 8, 2017
December 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Calcinosis cutis prevalence by radiographic assessment
at inclusion ( baseline)
Secondary Outcomes (7)
Demographic data
at inclusion ( baseline)
Rodnan score
at inclusion ( baseline)
Visceral localisation evaluation (cardiac, pulmonary, digestive)
at inclusion ( baseline)
EUSTAR score
at inclusion ( baseline)
Medsger score
at inclusion ( baseline)
- +2 more secondary outcomes
Study Arms (1)
Systemic sclerosis patients
Interventions
Radiography of the hand and feet (face incident) the day of the inclusion
Blood sample to analysis VEGF, endothelin 1, endostatin and P/GF, (ELISA method)
Eligibility Criteria
Systemic sclerosis patient in the national reference center for scleroderma (Lille, France)
You may qualify if:
- Systemic sclerosis presenting ACR-EULAR 2013 criteria
- Given their consent
- Titulary of health insurance
You may not qualify if:
- Dermatomyositis overlap
- Pregnant or breastfeeding women
- Imprisoned person
- Refuse of consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Claude Huriez, CHU
Lille, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vincent SOBANSKI, MD
University Hospital, Lille
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2017
First Posted
November 13, 2017
Study Start
November 30, 2017
Primary Completion
May 14, 2019
Study Completion
April 2, 2021
Last Updated
December 5, 2025
Record last verified: 2025-12