Evaluation of Calcinosis in Systemic Sclerosis (CALCIDERMIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03340194
Recruitment Status : Recruiting
First Posted : November 13, 2017
Last Update Posted : April 25, 2018
Information provided by (Responsible Party):
University Hospital, Lille

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.

Condition or disease Intervention/treatment
Systemic Sclerosis Radiation: Radiography Procedure: Veinous punction

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Actual Study Start Date : November 30, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

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)

Primary Outcome Measures :
  1. Calcinosis cutis prevalence by radiographic assessment [ Time Frame: at inclusion ( baseline) ]

Secondary Outcome Measures :
  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) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Systemic sclerosis patient in the national reference center for scleroderma (Lille, France)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03340194

Contact: Vincent SOBANSKI, MD 3 20 44 42 95 ext +33

Hôpital Claude Huriez, CHU Recruiting
Lille, France
Principal Investigator: Vincent Sobanski, MD         
Sponsors and Collaborators
University Hospital, Lille
Principal Investigator: Vincent SOBANSKI, MD University Hospital, Lille

Responsible Party: University Hospital, Lille Identifier: NCT03340194     History of Changes
Other Study ID Numbers: 2016_43
2017-A01822-51 ( Other Identifier: ID-RCB number, ANSM )
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Lille:
Systemic sclerosis
Calcinosis cutis

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Pathologic Processes
Connective Tissue Diseases
Skin Diseases
Calcium Metabolism Disorders
Metabolic Diseases