Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-26 @ 12:01 AM
Study NCT ID:
NCT06367894
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment Optimization and Nephrolithiasis Recurrence Prevention With Interdisciplinary Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007669', 'term': 'Kidney Calculi'}], 'ancestors': [{'id': 'D053040', 'term': 'Nephrolithiasis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052878', 'term': 'Urolithiasis'}, {'id': 'D014545', 'term': 'Urinary Calculi'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 164}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-11', 'studyFirstSubmitDate': '2024-04-11', 'studyFirstSubmitQcDate': '2024-04-11', 'lastUpdatePostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of acute renal colics', 'timeFrame': 'From first patient consultation till 31/10/2023', 'description': 'Number of acute renal colics'}, {'measure': 'Number of emergency admissions', 'timeFrame': 'From first patient consultation till 31/10/2023', 'description': 'Number of emergency admissions'}, {'measure': 'Number of surgeries', 'timeFrame': 'From first patient consultation till 31/10/2023', 'description': 'Number of surgeries'}, {'measure': 'Number of hospitalizations', 'timeFrame': 'From first patient consultation till 31/10/2023', 'description': 'Number of hospitalizations'}, {'measure': 'Identified genetics abnormalities', 'timeFrame': 'From first patient consultation till 31/10/2023', 'description': 'List of identified genetics abnormalities'}, {'measure': 'Wisconsin questionnaire', 'timeFrame': 'From first patient consultation till 31/10/2023', 'description': 'Changes in the quality of life in the patients (evolution of the scoring of the Wisconsin questionnaire)'}, {'measure': 'Kidney function outcome', 'timeFrame': 'Status at 31/10/2023', 'description': 'Kidney function outcome'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Kidney Stone']}, 'descriptionModule': {'briefSummary': "Nearly 10% of the Belgian population suffer from kidney stone disease. Recent reviews reported that kidney stones represent an underestimated risk factor for further kidney function deterioration. Preventive measures are recommended in lithiases patients to prevent the formation of new stones. The individual effects of different medicated prosthetic interventions have been documented in clinical trials. However, there is little data on the effectiveness of combining these different preventive measures in routine clinical practice (real-world context).\n\nPatients with kidney stone disease require a complete metabolic assessment. The three main factors contributing to the stone's formation are the patient's metabolism, diet and lifestyle. Metabolic work-up is recommended by the American Urology Association to identify and correct the factors responsible for urinary stone formation such as hypercalciuria, hyperoxaluria, hyperuricuria, hypocitraturia or abnormalities of urinary pH. The metabolic work-up includes at minimum the 24h urine test, a blood test and spot urine test. Dietary habits and lifestyle are assessed by means of a questionnaire.\n\nThe CHU Brugmann Hospital has a specialized multidisciplinary clinic for renal lithiases and mineral metabolism. Preventive personalized and interdisciplinary care in CHU Brugmann consists of a full metabolic work-up allowing the identification of lithogenic risk factors by nephrologists, dietary assessment by specialized dieticians and specific treatment protocol associated with regular follow-up.\n\nThe aim of this study is to evaluate, in the context of a retrospective single-center cohort study, the effect of preventive personalized and interdisciplinary care on the evolution of all urinary lithogenic risk factors and the recurrence of kidney stones (rate of renal colics, emergency room admissions, and urological interventions)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients of the CHU Brugmann Hospital who fulfill the criteria of active or past history of kidney stone, from 01/01/2018 till 31/10/2023', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients of the CHU Brugmann Hospital who fulfill the criteria of active or past history of kidney stone, from 01/01/2018 till 31/10/2023\n* Minimum follow-up time of 2 months with biochemical and clinical results available\n\nExclusion Criteria:\n\n\\- None'}, 'identificationModule': {'nctId': 'NCT06367894', 'briefTitle': 'Treatment Optimization and Nephrolithiasis Recurrence Prevention With Interdisciplinary Care', 'organization': {'class': 'OTHER', 'fullName': 'Brugmann University Hospital'}, 'officialTitle': 'Study on Treatment Optimization and Nephrolithiasis Recurrence Prevention With Interdisciplinary Care', 'orgStudyIdInfo': {'id': 'STONECARE'}}, 'contactsLocationsModule': {'locations': [{'zip': '1020', 'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Agnieszka POZDZIK', 'role': 'CONTACT', 'email': 'Agnieszka.POZDZIK@chu-brugmann.be', 'phone': '024772641'}, {'name': 'Sirika Chhem', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Brugmann', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'centralContacts': [{'name': 'Sirika Chhem', 'role': 'CONTACT', 'email': 'Sirika.Chhem@ulb.be', 'phone': '024772641'}, {'name': 'Agnieszka POZDZIK', 'role': 'CONTACT', 'email': 'Agnieszka.POZDZIK@chu-brugmann.be', 'phone': '024752639'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Agnieszka Pozdzik', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head of nephrology clinic', 'investigatorFullName': 'Agnieszka Pozdzik', 'investigatorAffiliation': 'Brugmann University Hospital'}}}}