Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2026-02-10 @ 12:02 PM
Study NCT ID:
NCT06430359
Status:
RECRUITING
Last Update Posted:
2025-11-26
First Post:
2024-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Circadian Variation of Urinary Copper Excretion in Wilson Disease Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006527', 'term': 'Hepatolenticular Degeneration'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020739', 'term': 'Brain Diseases, Metabolic, Inborn'}, {'id': 'D001928', 'term': 'Brain Diseases, Metabolic'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D008664', 'term': 'Metal Metabolism, Inborn Errors'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014554', 'term': 'Urination'}, {'id': 'D006403', 'term': 'Hematologic Tests'}], 'ancestors': [{'id': 'D014553', 'term': 'Urinary Tract Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': '3 urine collections of an 8h period. One blood sample for liver function test and copper assessment'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-02-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2024-05-21', 'studyFirstSubmitQcDate': '2024-05-21', 'lastUpdatePostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation factor', 'timeFrame': 'Two 24-hour urine recollection', 'description': 'Correlation between 24-hour urinary copper excretion and 8-hour urinary copper excretion collected between midnight and 8 am).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Wilson disease', 'urinary copper', 'chelator'], 'conditions': ['Wilson Disease']}, 'descriptionModule': {'briefSummary': "Wilson's disease (WD) is a genetic disorder characterized by an accumulation of copper in the body, mainly in the liver and brain. Patients suffering from this disease are monitored by liver function tests, blood copper levels, and 24-hour urinary copper determinations.\n\nTreatment is based either on chelating the copper accumulated in the body using D-penicillamine or Trientine or on limiting intestinal copper absorption with zinc salts.\n\nMonitoring copper elimination in urine collected over 24 hours is essential for estimating a patient's copper load, adapting treatment dosage, and detecting any copper deficiency.\n\nNevertheless, urine collection is often complicated for patients, given the obvious constraints of collecting urine over 24 hours. Without this, clinical decisions are usually made based on spot urine.\n\nThere is no official recommendation for monitoring urinary copper elimination other than on 24-hour urine.\n\nAccording to studies on healthy volunteers under physiological conditions, urinary copper elimination occurs according to a circadian rhythm, with minimal copper elimination between 8 pm and 4 am and maximum between 8 am and noon.\n\nThe study would aim to find the period of the day best correlated with 24h urinary copper excretion"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "\\- Patients with a confirmed diagnosis of Wilson's Disease (Leipzig score ˃4).", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with a confirmed diagnosis of Wilson's Disease (Leipzig score ˃4).\n* Age ≥ 6 years and ≤70 years.\n* Patient able to perform 24h urine.\n* Current treatment with D-Pencillamine, Trientine or Zinc.\n* Non-opposition of patient and/or legal representatives for minor patients.\n\nExclusion Criteria:\n\n* Patients who had a change in treatment within the last 6 months before the inclusion\n* Patients who have undergone liver transplantation\n* Patients with known chronic renal failure (GFR \\< 30 ml/min)\n* Patients on long-term diuretic or corticosteroid therapy\n* Persons deprived of liberty by a judicial or administrative decision\n* Patient under judicial protection, unable to express consent"}, 'identificationModule': {'nctId': 'NCT06430359', 'acronym': 'VARCUWIC', 'briefTitle': 'Circadian Variation of Urinary Copper Excretion in Wilson Disease Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Circadian Variation of Urinary Copper Excretion in Wilson Disease Patients Treated With Chelators or Zinc Salts', 'orgStudyIdInfo': {'id': '69HCL23_1227'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1 - DP', 'description': "Patients with a confirmed diagnosis of Wilson's Disease (Leipzig score ˃4 ). Aged between 6 years and 70 years. Treated with D-Pencillamine", 'interventionNames': ['Diagnostic Test: urine and blood test']}, {'label': 'Group 2 - Trientine', 'description': "Patients with a confirmed diagnosis of Wilson's Disease (Leipzig score ˃4 ). Aged between 6 years and 70 years. Treated with Trientine", 'interventionNames': ['Diagnostic Test: urine and blood test']}, {'label': 'Group 3 - ZINC', 'description': "Patients with a confirmed diagnosis of Wilson's Disease (Leipzig score ˃4 ). Aged between 6 years and 70 years. Treated with Zinc.", 'interventionNames': ['Diagnostic Test: urine and blood test']}], 'interventions': [{'name': 'urine and blood test', 'type': 'DIAGNOSTIC_TEST', 'description': '3 urine collections of an 8h period. One blood sample for liver function test and copper assessment', 'armGroupLabels': ['Group 1 - DP', 'Group 2 - Trientine', 'Group 3 - ZINC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69500', 'city': 'Bron', 'state': 'Rhone', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Eduardo Couchonnal, Dr', 'role': 'CONTACT', 'email': 'eduardo.couchonnal-bedoya@chu-lyon.fr', 'phone': '04 27 35 70 50', 'phoneExt': '+33'}, {'name': 'Abdelouahed BELMALIH, PhD', 'role': 'CONTACT', 'email': 'abdelouahed.belmalih@chu-lyon.fr', 'phone': '04 27 85 62 67', 'phoneExt': '+33'}], 'facility': 'Service de Gastroentérologie, Hépatologie et Nutrition Pédiatriques - Hôpital Femme Mère Enfant', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}], 'centralContacts': [{'name': 'Eduardo COUCHONNAL, Dr', 'role': 'CONTACT', 'email': 'eduardo.couchonnal-bedoya@chu-lyon.fr', 'phone': '04 27 35 70 50', 'phoneExt': '+33'}, {'name': 'Abdelouahed BELMALIH, PhD', 'role': 'CONTACT', 'email': 'abdelouahed.belmalih@chu-lyon.fr', 'phone': '04 27 85 62 67', 'phoneExt': '+33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}