Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT05271305
Status:
UNKNOWN
Last Update Posted:
2022-03-09
First Post:
2022-02-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pilot Study for a National Screening for Familial Hypercholesterolemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006938', 'term': 'Hyperlipoproteinemia Type II'}], 'ancestors': [{'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006951', 'term': 'Hyperlipoproteinemias'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-04', 'studyFirstSubmitDate': '2022-02-23', 'studyFirstSubmitQcDate': '2022-03-04', 'lastUpdatePostDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'familial hypercholesteromia', 'timeFrame': '2021-2024', 'description': 'percentage of screened primary school children with hypercholesterolemia'}], 'secondaryOutcomes': [{'measure': 'percentage of children screened', 'timeFrame': '2021-2024', 'description': 'number screened/number invited'}, {'measure': 'percentage of families screened', 'timeFrame': '2021-2024', 'description': 'index case family screening'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Familial Hypercholesterolemia']}, 'referencesModule': {'references': [{'pmid': '36600332', 'type': 'DERIVED', 'citation': 'Becker M, Adamski A, Fandel F, Vaillant M, Wagner K, Droste DW, Ziade B, Hein S, Mendon P, Bocquet V, de Beaufort C. Screening for familial hypercholesterolaemia in primary school children: protocol for a cross-sectional, feasibility study in Luxembourg city (EARLIE). BMJ Open. 2022 Dec 9;12(12):e066067. doi: 10.1136/bmjopen-2022-066067.'}]}, 'descriptionModule': {'briefSummary': 'A pilot study to study the feasibility of the screening of familial hypercholesterolemia within the setting of the legal medical visits at primary school.\n\nThe pilot study shall evaluate whether this screening set-up is efficient to detect patients having familial hypercholesterolemia, detect further patients by an adjacent cascade screening of family members, to deliver treatment to these patients and to provide this screening in a cost-effective manner.', 'detailedDescription': 'Pilot study evaluating the feasibility of a screening for familial hypercholesterolemia.\n\nCross-sectional design. Primary outcome Percentage of screened school children with confirmed familial hypercholesterolemia Participants All children, who attend a public primary school in the city of Luxembourg and are enrolled in the cycle C2.2 (age of 7-8 years; 3rd medical visit at school), cycle C3.2 (age 9-10 years, 4th medical visit at school) and cycle 4.2 (age 11-12 years, 5th medical visit at school) will be invited to participate. Expected number of invited children is around 1600 children/year.\n\nRecruitment will take place during the school year 2021/2022 and 2022/2023. The parents/caregivers of these children will receive written information about the screening. They will receive as well a questionnaire on the family history of premature cardiovascular events and known FHC disease.\n\nWithout informed consent, the child cannot be included in the screening program.\n\nAll children with signed informed consent will have a finger prick for a capillary blood test in the setting of their medical school exam by an external study nurse (not the school nurse) All data (pseudonymised) on each participant will be entered in the online data base for further analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All children, invited for their medical check through school medicine unit of the city of luxembourg, are invited to participate', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Attending primary school in the city of Luxembourg and invited for the legal medical visit\n\nExclusion Criteria:\n\n1\\. No parental informed consent'}, 'identificationModule': {'nctId': 'NCT05271305', 'acronym': 'EARLIE', 'briefTitle': 'Pilot Study for a National Screening for Familial Hypercholesterolemia', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier du Luxembourg'}, 'officialTitle': 'Pilot Study for a National Screening for Familial Hypercholesterolemia', 'orgStudyIdInfo': {'id': 'FHC'}}, 'contactsLocationsModule': {'locations': [{'zip': '1210', 'city': 'Luxembourg', 'country': 'Luxembourg', 'facility': 'CHde Luxembourg', 'geoPoint': {'lat': 49.60982, 'lon': 6.13268}}], 'overallOfficials': [{'name': 'Carine de Beaufort, MPhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHL'}, {'name': 'Marianne Becker, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier du Luxembourg', 'class': 'OTHER'}, 'collaborators': [{'name': 'Luxembourg Institute of Health', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor pediatrics', 'investigatorFullName': 'Carine de Beaufort', 'investigatorAffiliation': 'Centre Hospitalier du Luxembourg'}}}}