Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:27 AM
Study NCT ID:
NCT07356804
Status:
COMPLETED
Last Update Posted:
2026-01-21
First Post:
2018-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers in Pediatric Inflammatory Rheumatic Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001171', 'term': 'Arthritis, Juvenile'}, {'id': 'D000067251', 'term': 'Symptom Flare Up'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-12', 'studyFirstSubmitDate': '2018-11-13', 'studyFirstSubmitQcDate': '2026-01-12', 'lastUpdatePostDateStruct': {'date': '2026-01-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum Calprotectin in pediatric population with rheumatological inflammatory diseases', 'timeFrame': 'Months 3, 6, 9 and 12', 'description': 'To assess the clinical usefulness ofserum Calprotectin in pediatric population with rheumatological inflammatory diseases'}], 'secondaryOutcomes': [{'measure': 'Serum Amyloid Protein in pediatric population with rheumatological inflammatory diseases', 'timeFrame': 'Months 3, 6, 9 and 12', 'description': 'To assess the clinical usefulness of Serum Amyloid Protein in pediatric population with rheumatological inflammatory diseasesSedimentation Rate and the Clinical Criterion.\n\nDescribe the evolution over time of these markers.'}, {'measure': 'Correlation biomarkers', 'timeFrame': '1 year', 'description': 'Describe the correlation of Serum calportectin and Serum Amyloid Protein with the C-Reactive Protein, the Globular'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Calprotectin', 'Biomarkers'], 'conditions': ['Juvenile Idiopathic Arthritis', 'Flare Up, Symptom']}, 'descriptionModule': {'briefSummary': "A prospective study is proposed to serially determine new biomarkers: Calprotectin and Serum Amyloid Protein, alongside 'conventional' biomarkers: CRP and ESR, to help evaluate their utility in routine clinical practice", 'detailedDescription': "Pediatric inflammatory rheumatic diseases are relatively uncommon, but they represent the largest group of chronic diseases in childhood/adolescence and the leading cause of disability among children in developed countries. Poor control of the inflammatory activity of any of the aforementioned diseases can lead to growth failure (issues with growth and maturation), alterations in quality of life and school schedule for the patients, limitations secondary to joint impairments (especially in the case of JIA), and in the long term, the development of acquired amyloidosis (AA), which is a complication of any uncontrolled inflammatory process and significantly increases the morbidity and mortality of affected patients.The prognosis of pediatric inflammatory rheumatic diseases depends on the proper control of inflammation as well as the management of the immunosuppressive drugs used for this purpose. Even today, clinicians face many uncertainties in assessing the inflammatory status of our patients. Therefore, a prospective study is proposed to serially measure new biomarkers-Calprotectin and Serum Amyloid Protein-alongside 'conventional' biomarkers-CRP and ESR-to help evaluate their utility in routine clinical practice"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients in follow-up in our Pediatric Rheumatology Unit, with the diagnoses of: Juvenile Idiopathic Arthritis, Connective Diseases or Autoinflammatory Diseases', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients in follow-up in our Pediatric Rheumatology Unit, with the diagnoses of: Juvenile Idiopathic Arthritis, Connective Diseases or Autoinflammatory Diseases\n\nExclusion Criteria:\n\nNo'}, 'identificationModule': {'nctId': 'NCT07356804', 'acronym': 'BIRPED', 'briefTitle': 'Biomarkers in Pediatric Inflammatory Rheumatic Diseases', 'organization': {'class': 'OTHER', 'fullName': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}, 'officialTitle': 'Biomarkers in Pediatric Inflammatory Rheumatic Diseases', 'orgStudyIdInfo': {'id': 'IIBSP-BIR-2017-97'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Calprotectine', 'type': 'DIAGNOSTIC_TEST', 'description': 'Determination of calprotectin and amyloid protein in the serum of patients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08025', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Santa Creu i Sant Pau Hospital', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Berta Magallares', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau - IIB Sant Pau"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}