Systemic SclerosisCALCIDERMISNCT03340194
Evaluation of Calcinosis in Systemic Sclerosis
An observational study of Systemic Sclerosis, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- Radiography and Veinous punction
- Type of treatment
- Surgery or procedure
- How many people
- 214 participants
- Where
- 1 siteFrance
- Study dates
- 30 Nov 2017to 2 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Systemic sclerosis patient in the national reference center for scleroderma (Lille, France)
Who may be able to join
- Systemic sclerosis presenting ACR-EULAR 2013 criteria
- Given their consent
- Titulary of health insurance
Who cannot join
- Dermatomyositis overlap
- Pregnant or breastfeeding women
- Imprisoned person
- Refuse of consent
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Systemic Sclerosis
- Being tested
- Radiography, Veinous punction
- Keywords
- Systemic sclerosis, Calcinosis cutis
- Medical subject headings
- Scleroderma, Systemic, Calcinosis Cutis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiographyRadiation
Radiography of the hand and feet (face incident) the day of the inclusion
Veinous punctionProcedure or surgery
Blood sample to analysis VEGF, endothelin 1, endostatin and P/GF, (ELISA method)
| Study group | Role | What they receive |
|---|---|---|
| Systemic sclerosis patients | Not described Receives: Radiation: Radiography; Procedure: Veinous punction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calcinosis cutis prevalence by radiographic assessment
Measured: at inclusion ( baseline)
Secondary outcomes (7)
Demographic data
Measured: at inclusion ( baseline)
Rodnan score
Measured: at inclusion ( baseline)
Visceral localisation evaluation (cardiac, pulmonary, digestive)
Measured: at inclusion ( baseline)
EUSTAR score
Measured: at inclusion ( baseline)
Medsger score
Measured: at inclusion ( baseline)
Quality of life evaluation (HAQ modified questionary)
Measured: at inclusion ( baseline)
Biologic vascular markers : VEGF, endothelin 1, endostatin and P/GF, (ELISA method)
Measured: at inclusion ( baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start30 Nov 2017
- Primary completion14 May 2019
- Study completion2 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent SOBANSKI, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03340194
- Sponsor's protocol ID
- 2016_43
- Other IDs
- 2017-A01822-51
- Acronym
- CALCIDERMIS
- Status last verified
- Dec 2025
- First submitted
- 8 Nov 2017
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03340194
- Acronym / sponsor ID
- CALCIDERMIS / 2016_43
- Conditions
- Systemic Sclerosis
- Keywords
- Systemic sclerosis, Calcinosis cutis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 30 Nov 2017 (actual)
- Primary completion
- 14 May 2019 (actual)
- Study completion
- 2 Apr 2021 (actual)
- First posted
- 13 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Systemic sclerosis patients | – | Radiation: Radiography, Procedure: Veinous punction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Systemic sclerosis patient in the national reference center for scleroderma (Lille, France)
Key inclusion criteria (3 listed)
- Systemic sclerosis presenting ACR-EULAR 2013 criteria
- Given their consent
- Titulary of health insurance
Key exclusion criteria (4 listed)
- Dermatomyositis overlap
- Pregnant or breastfeeding women
- Imprisoned person
- Refuse of consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiographyRadiography of the hand and feet (face incident) the day of the inclusion | Radiation | Systemic sclerosis patients |
| Veinous punctionBlood sample to analysis VEGF, endothelin 1, endostatin and P/GF, (ELISA method) | Procedure or surgery | Systemic sclerosis patients |
Primary outcome
Calcinosis cutis prevalence by radiographic assessment
Time frame: at inclusion ( baseline)
7 secondary outcomes
Demographic data
Time frame: at inclusion ( baseline)
Rodnan score
Time frame: at inclusion ( baseline)
Visceral localisation evaluation (cardiac, pulmonary, digestive)
Time frame: at inclusion ( baseline)
EUSTAR score
Time frame: at inclusion ( baseline)
Medsger score
Time frame: at inclusion ( baseline)
Quality of life evaluation (HAQ modified questionary)
Time frame: at inclusion ( baseline)
Biologic vascular markers : VEGF, endothelin 1, endostatin and P/GF, (ELISA method)
Time frame: at inclusion ( baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
Related trials for Systemic Sclerosis
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Patient Reported Outcomes With UVA-1 Therapy for Treatment of Sclerosing Skin Diseases
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A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2)
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Active, not recruitingObservational study
Cross-cultural Adaptation and Validation of the Localised Scleroderma Quality of Life Instrument (LoSQI) in Juvenile Localised Scleroderma (JLS)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent SOBANSKI, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Sclerosis, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calcinosis cutis prevalence by radiographic assessment (time frame: at inclusion ( baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.