Evaluation of Calcinosis in Systemic Sclerosis

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03340194

Acronym

CALCIDERMIS

Enrollment

214

Registered

2017-11-13

Start date

2017-11-30

Completion date

2021-04-02

Last updated

2025-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Sclerosis

Keywords

Systemic sclerosis, Calcinosis cutis

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.

Interventions

RADIATIONRadiography

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

PROCEDUREVeinous punction

Blood sample to analysis VEGF, endothelin 1, endostatin and P/GF, (ELISA method)

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Calcinosis cutis prevalence by radiographic assessment	at inclusion ( baseline)

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026