Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT06517927
Status:
RECRUITING
Last Update Posted:
2024-11-19
First Post:
2024-07-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevalence of Long-term Dental Effects of Chemotherapy in Childhood Cancer Survivors Diagnosed With Cancer Before the Age of 10
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}, {'id': 'D008310', 'term': 'Malocclusion'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Interventionnal study, cohort study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 142}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-05-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-15', 'studyFirstSubmitDate': '2024-07-18', 'studyFirstSubmitQcDate': '2024-07-18', 'lastUpdatePostDateStruct': {'date': '2024-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of the caries experience by using the Decay Missing Filled Teeth score (DMFT)', 'timeFrame': 'Thoughout the entire study, approximately during 2 years', 'description': 'Assess the impact of the chemotherapy agents on the risk of ulterior caries development'}], 'secondaryOutcomes': [{'measure': 'Assessment of the prevalence of dental development defects (DDD)', 'timeFrame': 'Thoughout the entire study, approximately during 2 years', 'description': 'Assess the impact of the chemotherapy agents on the risk of ulterior dental development defect'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Childhood cancer survivors', 'Dental defect'], 'conditions': ['Chemotherapy Effect', 'Dental Caries', 'Malocclusion', 'Childhood Cancer', 'Tooth Defect']}, 'descriptionModule': {'briefSummary': 'To date, there are no methods for assessing the risk of oral developmental defects that could predict long-term adverse effects in childhood cancer survivors. Having such a method at our disposal would enable us to better assess the risk to develop those defects and will help us provide new prevention and treatment strategies to ensure a healthy oral development.\n\nThe aims of this study are :\n\n* Assess the caries risk in childhood cancer survivors compared with a control group.\n* Assess the dental development defects risk in childhood cancer survivors compared with a control group.', 'detailedDescription': 'This will be an international study comparing the Childhood Cancer Survivors (CCS) and a control group.\n\nA questionnaire will be provided to the patients to gather information. A standard of care dental examination will then take place in a dental office in the Cliniques Universitaires Saint-Luc. We also collect medical data to complete the files.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '36 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age below 10 at cancer diagnosis (for the CCS group).\n* Chemotherapy must have been used to treat the patient (For the CCS group).\n* The patient is 12 years old or older at the time of the follow-up appointment of the present study\n\nExclusion Criteria:\n\n* A patient who was diagnosed and treated after 10 years old.\n* Patient below 12 years old at time of study recruitment\n* Patients with syndrome or diseases that involve teeth impairment\\*\n* Pregnant patient\n* Refusal or inaptitude to undergo dental and radiographic examination'}, 'identificationModule': {'nctId': 'NCT06517927', 'briefTitle': 'Prevalence of Long-term Dental Effects of Chemotherapy in Childhood Cancer Survivors Diagnosed With Cancer Before the Age of 10', 'organization': {'class': 'OTHER', 'fullName': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}, 'officialTitle': 'Prevalence of Long-term Dental Effects of Chemotherapy in Childhood Cancer Survivors Diagnosed With Cancer Before the Age of 10', 'orgStudyIdInfo': {'id': 'DENTAL CHEMO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cancer survivor', 'interventionNames': ['Diagnostic Test: Clinical and radiographic dental examination']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'interventionNames': ['Diagnostic Test: Clinical and radiographic dental examination']}], 'interventions': [{'name': 'Clinical and radiographic dental examination', 'type': 'DIAGNOSTIC_TEST', 'description': 'complete clinical oral examination + intra-oral and panoramic x-rays', 'armGroupLabels': ['Cancer survivor', 'Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1200', 'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Maëlle De Ville de Goyet', 'role': 'CONTACT', 'email': 'maelle.deville@saintluc.uclouvain.be'}], 'facility': 'Cliniques universitaires Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'centralContacts': [{'name': 'Armand IRAKOZE', 'role': 'CONTACT', 'email': 'armand.irakoze@uclouvain.be', 'phone': '027645741', 'phoneExt': '+32'}], 'overallOfficials': [{'name': 'Maëlle De Ville de Goyet', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}