Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2026-01-07 @ 4:12 AM
Study NCT ID:
NCT05385757
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-10-04
First Post:
2020-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
UNICORNS: Uveitis in Childhood Prospective National Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014605', 'term': 'Uveitis'}], 'ancestors': [{'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-15', 'size': 295594, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-05-03T18:24', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Saliva, Stool, Tears and Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-03', 'studyFirstSubmitDate': '2020-10-16', 'studyFirstSubmitQcDate': '2022-05-19', 'lastUpdatePostDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of ocular complications', 'timeFrame': 'Up to 3 years', 'description': 'New incident of sight threatening ocular complications, including glaucoma, cataract and macular oedema'}, {'measure': 'Pediatric Quality of Life Inventory Score', 'timeFrame': 'Up to 3 years', 'description': 'Quality of life (patient reported outcomes) using Pediatric Quality of Life Inventory (PedsQL) in which items are reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better HRQOL (Health-Related Quality of Life)'}], 'secondaryOutcomes': [{'measure': 'Corticosteroid exposure', 'timeFrame': 'Up to 3 years', 'description': 'Total prescribed topical and systemic corticosteroid burden'}, {'measure': 'Attainment of disease control', 'timeFrame': 'Up to 3 years', 'description': 'Number of children achieving absolute control defined as absence of inflammation Relative control defined as the absence of inflammation greater than 0.5 The lowest grade of inflammation, with the use of less than one drop of topical corticosteroid'}, {'measure': 'Health Utility', 'timeFrame': 'Up to 3 years', 'description': 'Child Health Utility Metric (CHU9D), with scores ranging from 0.33 (worst health state) to 1.00 (best health state)'}, {'measure': 'Change in Pediatric Quality of Life Inventory Score', 'timeFrame': 'Over one year from baseline to year one', 'description': 'Change in child reported quality of life using Pediatric Quality of Life Inventory (PedsQL) in which items are reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better HRQOL (Health-Related Quality of Life), and a change of greater than 5 is clinically meaningful'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Quality of life', 'Child', 'Prospective Cohort', 'Vision'], 'conditions': ['Uveitis']}, 'referencesModule': {'references': [{'pmid': '38435080', 'type': 'BACKGROUND', 'citation': 'Kellett S, Rahi JS, Dick AD, Knowles R, Tadic V, Solebo AL. UNICORNS: Uveitis in childhood prospective national cohort study protocol. F1000Res. 2023 Aug 30;9:1196. doi: 10.12688/f1000research.26689.2. eCollection 2020.'}], 'seeAlsoLinks': [{'url': 'http://www.ucl.ac.uk/child-health/unicorns', 'label': 'Study Website'}, {'url': 'http://www.youtube.com/channel/UCRkMbO7q5sN8M_0RtggBDyQ', 'label': 'Study Video'}]}, 'descriptionModule': {'briefSummary': 'Childhood uveitis (inflammation inside the eye) is an uncommon disorder that carries the risk of blindness. Inadequate treatment of active inflammation has been shown to be related to a poor outcome. There has been no population-based, prospective longitudinal study of all-cause childhood uveitis, with resultant limitations in the evidence base used to counsel affected families, balance treatment decisions, or plan further research. The aim of the study is to describe the characteristics of childhood-onset uveitis and describe outcomes. The investigators shall also aim to identify the socio-demographic, clinical, biological and treatment-related determinants of outcome. Early (1-2 years following diagnosis) outcomes will be described in the first instance: However, through the creation of a national inception cohort, the investigators shall enable longer-term studies of outcome for affected children and families. There will be no change to routine clinical care.', 'detailedDescription': "Background:\n\nChildhood uveitis descriptive term for a group of rare inflammatory eye disease, which are typically chronic, relapsing-remitting in nature, and of uncertain aetiology (idiopathic). Visual loss occurs due to structural damage caused by uncontrolled inflammation. Understanding of the determinants of long-term outcome is limited, particularly the predictors of therapeutic response or how to define disease control.\n\nAims:\n\nTo describe disease natural history and outcomes amongst a nationally representative group of children with non-infectious uveitis, describe the impact of disease course on quality of life for both child and family, and identify determinants of adverse visual, structural and developmental outcomes.\n\nMethods:\n\nUNICORNS is a prospective longitudinal multicentre cohort study of children newly diagnosed with uveitis about whom a core minimum clinical dataset will be collected. Participants and their families will also complete patient-reported outcome measures (PROMS) at study entry and annually from recruitment.\n\nPROMS collected at baseline are:\n\n* Strength and Difficulties Questionnaire (SDQ): this is to screen the emotional and behavioural aspects of the participants' lives\n* Child Health Utility 9D (CHU9D): generic preference based measure of health related quality of life\n* Children's Sleep Habits Questionnaire (CHSQ): this evaluates incidence of behaviours linked with typical paediatric sleep difficulties\n* 100-mm General Evaluation (GE): visual analogue score 100mm long used to capture overall perception of the burden of disease\n\nPROMS collected at year 1 and annually (subject to investigations of instrument redundancy) are:\n\n* Child Health Utility 9D (CHU9D): generic preference based measure of health related quality of life\n* 100-mm General Evaluation (GE): visual analogue score 100mm long used to capture overall perception of the burden of disease\n* Paediatric Quality of life Score (PedsQL): a brief questionnaire used to evaluate health related quality of life in children\n* Vision related quality of life metric - Children and Young People (VQoL\\_CYP): these instruments captures the functional and broader impacts of living with a visual disability The association of patient (child- and treatment- dependent) characteristics with outcome will be investigated using logistic and ordinal regression models which incorporate adjustment for within-child correspondence between eyes for those with bilateral disease and repeated outcomes measurement.\n\nDiscussion:\n\nThrough this population based, prospective longitudinal study of childhood uveitis, the investigators will describe the characteristics of childhood onset disease. Early (1-2 years following diagnosis) outcomes will be described in the first instance, and through the creation of a national inception cohort, longer term studies of outcome for affected children and families will be enabled."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children those aged under 18 years old (at diagnosis) who are newly diagnosed with uveitis newly diagnosed with uveitis (within previous 6 months)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children newly diagnosed with uveitis (within previous 6 months)\n* Age \\< 18years\n\nExclusion Criteria:\n\n* Uveitis due to malignancy\n* Uveitis due to ocular trauma (including iatrogenic, ie intraocular surgery)\n* Uveitis due to confirmed ocular infection\n* Children with developmental disorders or impairments which prevent their self-report of their function level or quality of life'}, 'identificationModule': {'nctId': 'NCT05385757', 'acronym': 'UNICORNS', 'briefTitle': 'UNICORNS: Uveitis in Childhood Prospective National Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Child Health'}, 'officialTitle': 'Uveitis in Childhood Prospective National Cohort Study', 'orgStudyIdInfo': {'id': '258638'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Childhood Uveitis', 'description': 'Children \\<18 years old newly diagnosed with non-infectious uveitis'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BT9 7AB', 'city': 'Belfast', 'country': 'United Kingdom', 'facility': 'Belfast Royal Victoria Hospital NHS Foundation Trust', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}, {'zip': 'B4 6NH', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': "Birmingham Women's and Children's Hospital NHS Foundation Trust", 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'BH7 7DW', 'city': 'Bournemouth', 'country': 'United Kingdom', 'facility': 'Royal Bournemouth Christchurch Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 50.72048, 'lon': -1.8795}}, {'zip': 'BD9 6RJ', 'city': 'Bradford', 'country': 'United Kingdom', 'facility': 'Bradford Teaching Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 53.79391, 'lon': -1.75206}}, {'zip': 'BS1 3NU', 'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'University Hospitals Bristol NHS Foundation Trust', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'CB2 0QQ', 'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Cambridge University Hospital NHS Foundation Trust', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'CF14 4XW', 'city': 'Cardiff', 'country': 'United Kingdom', 'facility': 'Cardiff and Vale University Health Board Hospitals', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'zip': 'CM1 7ET', 'city': 'Chelmsford', 'country': 'United Kingdom', 'facility': 'Mid Essex Hospital Trust', 'geoPoint': {'lat': 51.73575, 'lon': 0.46958}}, {'zip': 'DD1 9SY', 'city': 'Dundee', 'country': 'United Kingdom', 'facility': 'Ninewells Hospital', 'geoPoint': {'lat': 56.46913, 'lon': -2.97489}}, {'zip': 'EH1 3EG', 'city': 'Edinburgh', 'country': 'United Kingdom', 'facility': 'Princess Alexandra Eye Pavilion', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'zip': 'G51 4TF', 'city': 'Glasgow', 'country': 'United Kingdom', 'facility': "Royal Children's Hospital", 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'NR31 6LA', 'city': 'Great Yarmouth', 'country': 'United Kingdom', 'facility': 'James Paget University Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 52.60831, 'lon': 1.73052}}, {'zip': 'HU3 2JZ', 'city': 'Hull', 'country': 'United Kingdom', 'facility': 'Hull University Teaching Hospitals NHS Trust', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}, {'zip': 'LS9 7TF', 'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'Leeds Teaching Hospitals NHS Trust', 'geoPoint': {'lat': 53.79648, 'lon': 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Kingdom', 'facility': "Sussex Eye Hospital and Royal Alexandra Children's Hospital", 'geoPoint': {'lat': 51.24048, 'lon': -0.17044}}, {'zip': 'S10 2TH', 'city': 'Sheffield', 'country': 'United Kingdom', 'facility': "Sheffield Children's Hospitals NHS Foundation Trust", 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'zip': 'SO16 6YD', 'city': 'Southampton', 'country': 'United Kingdom', 'facility': 'University Hospital Southampton NHS Foundation Trust', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}, {'zip': 'SS0 0RY', 'city': 'Westcliff-on-Sea', 'country': 'United Kingdom', 'facility': 'Southend University Hospital NHS Foundation Trust', 'geoPoint': {'lat': 51.54424, 'lon': 0.69179}}, {'zip': 'E1 1FR', 'city': 'Whitechapel', 'country': 'United Kingdom', 'facility': 'Royal London Hospital', 'geoPoint': {'lat': 51.51382, 'lon': -0.06583}}, {'zip': 'YO31 8HE', 'city': 'York', 'country': 'United Kingdom', 'facility': 'York Teaching Hospital NHS Foundation Trust', 'geoPoint': {'lat': 53.95763, 'lon': -1.08271}}], 'overallOfficials': [{'name': 'Ameenat L Solebo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University College London (UCL) Great Ormond Street Institute of Child Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Authorised collaborators will be granted access to aggregated anonymised data, following review of their research protocol study PI and Co-Is. Data and material transfer agreements will be required to be completed, in order to ensure regulatory compliance and that the interests of the participants are upheld and respected throughout.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Child Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute for Health Research, United Kingdom', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}