Skip to main content
OpenTrials
Completed

NCT Number: NCT03340194

Evaluation of Calcinosis in Systemic Sclerosis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Systemic Sclerosis Calcinosis Calcinosis Cutis Calcium Metabolism Disorders Connective Tissue Diseases Metabolic Diseases Nutritional and Metabolic Diseases Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Claude Huriez, CHU

Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiography

Radiation

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

Veinous punction

Procedure

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

Primary outcomes

  1. Calcinosis cutis prevalence by radiographic assessment

    Time frame: at inclusion ( baseline)

Secondary outcomes

  1. Demographic data

    Time frame: at inclusion ( baseline)

  2. Rodnan score

    Time frame: at inclusion ( baseline)

  3. Visceral localisation evaluation (cardiac, pulmonary, digestive)

    Time frame: at inclusion ( baseline)

  4. EUSTAR score

    Time frame: at inclusion ( baseline)

  5. Medsger score

    Time frame: at inclusion ( baseline)

  6. Quality of life evaluation (HAQ modified questionary)

    Time frame: at inclusion ( baseline)

  7. Biologic vascular markers : VEGF, endothelin 1, endostatin and P/GF, (ELISA method)

    Time frame: at inclusion ( baseline)

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study 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

Acronym: CALCIDERMIS

Important dates

Study start
2017
Primary completion
2019
Study completion
2021
First posted
Nov 13, 2017
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.