Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2025-12-31 @ 4:16 AM
Study NCT ID:
NCT06444503
Status:
RECRUITING
Last Update Posted:
2024-09-25
First Post:
2024-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinico-biological Collection of Bone, Calcium and Growth Plate Pathologies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001847', 'term': 'Bone Diseases'}], 'ancestors': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001688', 'term': 'Biological Products'}], 'ancestors': [{'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood, urine, other body fluids and tissues biopsies'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2034-09-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-23', 'studyFirstSubmitDate': '2024-05-30', 'studyFirstSubmitQcDate': '2024-05-30', 'lastUpdatePostDateStruct': {'date': '2024-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2034-09-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Building a collection of biological samples and clinical-biological data from patients presenting bone, calcium and growth plate pathologies', 'timeFrame': 'Day 0 and through study completion, an average of 5 years', 'description': 'Blood and urine sampling'}], 'secondaryOutcomes': [{'measure': 'Identification of potential markers of disease progression based on new knowledge.', 'timeFrame': 'Day 0 and through study completion, an average of 5 years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bone Disorder']}, 'descriptionModule': {'briefSummary': 'The aim of this project is to set up a biological and clinical collection of patients with progressive bone, calcium and growth plate pathologies.\n\nThis collection will provide a better understanding of the mechanisms involved in growth plate and bone damage in these diseases and identify factors predictive of progression and new therapeutic targets.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with with growth plate or bone pathology.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children (from birth) with growth plate or bone pathology\n* Patients affiliated to or benefiting from a social security scheme\n* Patients able to receive information about the study and to understand the information form in order to participate in the study. This implies :\n* mastery of the French language\n* Not being subject to a restriction of rights by the judicial authorities\n* Patients or legal representatives having given their consent to participate in the study (expression of non-opposition).\n\nExclusion Criteria:\n\n* Patients under legal protection (guardianship, curatorship or safeguard of justice)\n* Pregnant or breast-feeding women'}, 'identificationModule': {'nctId': 'NCT06444503', 'acronym': 'OSCAR', 'briefTitle': 'Clinico-biological Collection of Bone, Calcium and Growth Plate Pathologies', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Creation of a Biological Collection to Study the Pathophysiology and Identify Predictive Factors for the Evolution of Bone, Calcium and Growth Plate Pathologies', 'orgStudyIdInfo': {'id': 'RC31/24/0214'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients suffering from growth plate or bone pathology', 'description': 'As part of their pathology, patients benefit from clinical monitoring and regular blood and urine tests.', 'interventionNames': ['Other: Biological samples', 'Other: Biological']}], 'interventions': [{'name': 'Biological samples', 'type': 'OTHER', 'description': 'Blood and urine will be taken in larger quantity', 'armGroupLabels': ['Patients suffering from growth plate or bone pathology']}, {'name': 'Biological', 'type': 'OTHER', 'description': 'Surgical residues may be preserved in the event of surgery carried out as part of the treatment.', 'armGroupLabels': ['Patients suffering from growth plate or bone pathology']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31000', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Thomas EDOUARD, MD', 'role': 'CONTACT', 'email': 'edouard.t@chu-toulouse.fr', 'phone': '0534558555', 'phoneExt': '+33'}, {'name': 'Thomas EDOUARD, MD', 'role': 'CONTACT'}], 'facility': 'University Toulouse Hospital', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Thomas EDOUARD, MD', 'role': 'CONTACT', 'email': 'edouard.t@chu-toulouse.fr', 'phone': '0534558555', 'phoneExt': '+33'}, {'name': 'Sanaa EDDIRY', 'role': 'CONTACT', 'email': 'eddiry.s@chu-toulouse.fr', 'phone': '0561776110', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Thomas EDOUARD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}