Evaluation of Calcinosis in Systemic Sclerosis (CALCIDERMIS)

December 4, 2025 updated by: University Hospital, Lille

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

214

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France
        • Hôpital Claude Huriez, CHU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Systemic sclerosis patient in the national reference center for scleroderma (Lille, France)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Systemic sclerosis patients
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Calcinosis cutis prevalence by radiographic assessment
Time Frame: at inclusion ( baseline)
at inclusion ( baseline)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: Vincent Sobanski, MD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2017

Primary Completion (Actual)

May 14, 2019

Study Completion (Actual)

April 2, 2021

Study Registration Dates

First Submitted

November 8, 2017

First Submitted That Met QC Criteria

November 8, 2017

First Posted (Actual)

November 13, 2017

Study Record Updates

Last Update Posted (Estimated)

December 5, 2025

Last Update Submitted That Met QC Criteria

December 4, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016_43
  • 2017-A01822-51 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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