Ignite Creation Date:
2025-12-25 @ 1:35 AM
Ignite Modification Date:
2026-01-04 @ 6:30 PM
Study NCT ID:
NCT03340194
Status:
COMPLETED
Last Update Posted:
2025-12-05
First Post:
2017-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Calcinosis in Systemic Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012595', 'term': 'Scleroderma, Systemic'}, {'id': 'D000092182', 'term': 'Calcinosis Cutis'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D002114', 'term': 'Calcinosis'}, {'id': 'D002128', 'term': 'Calcium Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014965', 'term': 'X-Rays'}], 'ancestors': [{'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D011839', 'term': 'Radiation, Ionizing'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 214}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2021-04-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2017-11-08', 'studyFirstSubmitQcDate': '2017-11-08', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Calcinosis cutis prevalence by radiographic assessment', 'timeFrame': 'at inclusion ( baseline)'}], 'secondaryOutcomes': [{'measure': 'Demographic data', 'timeFrame': 'at inclusion ( baseline)'}, {'measure': 'Rodnan score', 'timeFrame': 'at inclusion ( baseline)'}, {'measure': 'Visceral localisation evaluation (cardiac, pulmonary, digestive)', 'timeFrame': 'at inclusion ( baseline)'}, {'measure': 'EUSTAR score', 'timeFrame': 'at inclusion ( baseline)'}, {'measure': 'Medsger score', 'timeFrame': 'at inclusion ( baseline)'}, {'measure': 'Quality of life evaluation (HAQ modified questionary)', 'timeFrame': 'at inclusion ( baseline)'}, {'measure': 'Biologic vascular markers : VEGF, endothelin 1, endostatin and P/GF, (ELISA method)', 'timeFrame': 'at inclusion ( baseline)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Systemic sclerosis', 'Calcinosis cutis'], 'conditions': ['Systemic Sclerosis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Systemic sclerosis patient in the national reference center for scleroderma (Lille, France)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Systemic sclerosis presenting ACR-EULAR 2013 criteria\n* Given their consent\n* Titulary of health insurance\n\nExclusion Criteria:\n\n* Dermatomyositis overlap\n* Pregnant or breastfeeding women\n* Imprisoned person\n* Refuse of consent'}, 'identificationModule': {'nctId': 'NCT03340194', 'acronym': 'CALCIDERMIS', 'briefTitle': 'Evaluation of Calcinosis in Systemic Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '2016_43'}, 'secondaryIdInfos': [{'id': '2017-A01822-51', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Systemic sclerosis patients', 'interventionNames': ['Radiation: Radiography', 'Procedure: Veinous punction']}], 'interventions': [{'name': 'Radiography', 'type': 'RADIATION', 'description': 'Radiography of the hand and feet (face incident) the day of the inclusion', 'armGroupLabels': ['Systemic sclerosis patients']}, {'name': 'Veinous punction', 'type': 'PROCEDURE', 'description': 'Blood sample to analysis VEGF, endothelin 1, endostatin and P/GF, (ELISA method)', 'armGroupLabels': ['Systemic sclerosis patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lille', 'country': 'France', 'facility': 'Hôpital Claude Huriez, CHU', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Vincent SOBANSKI, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}