Evaluation of Calcinosis in Systemic Sclerosis

NCT ID: NCT03340194

Last Updated: 2025-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

214 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-30

Study Completion Date

2021-04-02

Brief Summary

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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.

Detailed Description

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Conditions

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Systemic Sclerosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Systemic sclerosis patients

Radiography

Intervention Type RADIATION

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

Veinous punction

Intervention Type PROCEDURE

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

Interventions

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Radiography

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

Intervention Type RADIATION

Veinous punction

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vincent SOBANSKI, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hôpital Claude Huriez, CHU

Lille, , France

Site Status

Countries

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France

Other Identifiers

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2017-A01822-51

Identifier Type: OTHER

Identifier Source: secondary_id

2016_43

Identifier Type: -

Identifier Source: org_study_id

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