Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2026-01-02 @ 6:23 PM
Study NCT ID:
NCT06092203
Status:
UNKNOWN
Last Update Posted:
2023-10-23
First Post:
2023-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Life for Pediatric Urolithiasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D052878', 'term': 'Urolithiasis'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System 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': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-15', 'studyFirstSubmitDate': '2023-10-10', 'studyFirstSubmitQcDate': '2023-10-15', 'lastUpdatePostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The PedsQL questionnaire', 'timeFrame': '12 months', 'description': 'comparison of overall PedsQL score between pediatric urolithiasis patients and normal healthy age/sex matched population.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Urolithiasis', 'Quality of life', 'PCNL', 'SWL'], 'conditions': ['Pediatric ALL']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the quality of life (QoL) in pediatric patients with urinary stone disease.', 'detailedDescription': 'This study will assess the quality of life (QoL) in pediatric patients with urinary stone disease using the pediatric quality of life (PedsQol) questionnaire in comparison to normal healthy age/sex matched population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All pediatric patients with urolithiasis.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who had urinary stones\n\nExclusion Criteria:\n\n1. Patients presenting with obstructive uropathy or urosepsis.\n2. Recent (less than 4 weeks) surgical intervention for urinary stone disease.\n3. Indwelling urinary catheters or stents (urethral catheter, ureteral stents or nephrostomy tube).\n4. Associated mental illness or cognitive dysfunction.\n5. Associated chronic medical illness that may compromise QoL.'}, 'identificationModule': {'nctId': 'NCT06092203', 'acronym': 'Elattar', 'briefTitle': 'Quality of Life for Pediatric Urolithiasis', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Assessment of Health-Related Quality of Life for Pediatric Patients With Urinary Stone Disease.', 'orgStudyIdInfo': {'id': '2278'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'Pediatric patients who underwent treatment for utrollithiasis.'}, {'label': 'Control', 'description': 'Cross-matched group of healthy children.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed R EL-Nahas, MD', 'role': 'CONTACT', 'email': 'ar_el_nahas@yahoo.com', 'phone': '00201221136899'}, {'name': 'M', 'role': 'CONTACT'}], 'facility': 'Urology and Nephrology Center', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'centralContacts': [{'name': 'Ahmed R EL-Nahas, MD', 'role': 'CONTACT', 'email': 'ar_el_nahas@yahoo.com', 'phone': '+201221136899'}], 'overallOfficials': [{'name': 'Ahmed R EL-Nahas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mansoura University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Urology', 'investigatorFullName': 'Ahmed R. EL-Nahas', 'investigatorAffiliation': 'Mansoura University'}}}}