Ignite Creation Date:
2025-12-24 @ 2:13 PM
Ignite Modification Date:
2026-03-01 @ 10:09 AM
Study NCT ID:
NCT02124395
Status:
COMPLETED
Last Update Posted:
2022-09-02
First Post:
2014-04-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Health-related Quality of Life in Rare Kidney Stone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006960', 'term': 'Hyperoxaluria, Primary'}, {'id': 'D003555', 'term': 'Cystinuria'}, {'id': 'C538228', 'term': 'Adenine phosphoribosyltransferase deficiency'}, {'id': 'D057973', 'term': 'Dent Disease'}], 'ancestors': [{'id': 'D006959', 'term': 'Hyperoxaluria'}, {'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': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002239', 'term': 'Carbohydrate 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': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D000608', 'term': 'Renal Aminoacidurias'}, {'id': 'D015499', 'term': 'Renal Tubular Transport, Inborn Errors'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011788', 'term': 'Quality of Life'}], 'ancestors': [{'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 365}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-31', 'studyFirstSubmitDate': '2014-04-23', 'studyFirstSubmitQcDate': '2014-04-24', 'lastUpdatePostDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of HRQoL in patients with rare kidney stones', 'timeFrame': 'Once a year for up to 5 years after signed consent', 'description': 'Assessment of HRQoL in patients with rare kidney stones. Comparison of HRQoL results between rare kidney stone formers, general population and other populations with relevant chronic diseases'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primary Hyperoxaluria', 'Cystinuria', 'Adenine Phosphoribosyl Transferase Deficiency', 'Dent Disease']}, 'referencesModule': {'references': [{'pmid': '24253538', 'type': 'BACKGROUND', 'citation': 'Modersitzki F, Pizzi L, Grasso M, Goldfarb DS. Health-related quality of life (HRQoL) in cystine compared with non-cystine stone formers. Urolithiasis. 2014 Feb;42(1):53-60. doi: 10.1007/s00240-013-0621-4. Epub 2013 Nov 20.'}]}, 'descriptionModule': {'briefSummary': 'Assessment of Health-related Quality of Life in Rare Kidney Stone Formers in the Rare Kidney Stone Consortium', 'detailedDescription': "The purpose of this study is to learn about Health-related Quality Of Life (HRQoL) in patients enrolled in the Rare Kidney Stone Consortium (RKSC) registries. Quality of life studies look at different aspects of both physical and mental components of people's lives. HRQoL data for people affected by kidney stones are not currently available for people followed over time."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Sample will be selected from the Rare Kidney Stone Consortium registries', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Qualify to participate in one of the Rare Kidney Stone Registries.\n* Be at least 5 years old (for SF-10)\n* Are able to communicate using the English language\n* Consent to participate in the study (or "assent" if under 18 years old)\n* Have internet access with an email account or a valid home address\n\nExclusion Criteria:\n\nNone, if inclusion criteria are met'}, 'identificationModule': {'nctId': 'NCT02124395', 'briefTitle': 'Health-related Quality of Life in Rare Kidney Stone', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Assessment of Health-related Quality of Life in Rare Kidney Stone Formers in the Rare Kidney Stone Consortium', 'orgStudyIdInfo': {'id': '13-00968'}, 'secondaryIdInfos': [{'id': '1U54DK083908-01', 'link': 'https://reporter.nih.gov/quickSearch/1U54DK083908-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Primary Hyperoxaluria', 'description': 'All rare kidney stone patients enrolled in RKSC registries that are able to communicate using the English language, are able to consent to participation in the study, have internet access with an email account and/or a valid address and are at minimum 5 years of age (for SF-10)', 'interventionNames': ['Other: Health-related Quality of Life in Rare Kidney Stone Questionnaire']}, {'label': 'Cystinuria', 'description': 'All rare kidney stone patients enrolled in RKSC registries that are able to communicate using the English language, are able to consent to participation in the study, have internet access with an email account and/or a valid address and are at minimum 5 years of age (for SF-10)', 'interventionNames': ['Other: Health-related Quality of Life in Rare Kidney Stone Questionnaire']}, {'label': 'Dent Disease', 'description': 'All rare kidney stone patients enrolled in RKSC registries that are able to communicate using the English language, are able to consent to participation in the study, have internet access with an email account and/or a valid address and are at minimum 5 years of age (for SF-10)', 'interventionNames': ['Other: Health-related Quality of Life in Rare Kidney Stone Questionnaire']}, {'label': 'APRT deficiency', 'description': 'All rare kidney stone patients enrolled in RKSC registries that are able to communicate using the English language, are able to consent to participation in the study, have internet access with an email account and/or a valid address and are at minimum 5 years of age (for SF-10)', 'interventionNames': ['Other: Health-related Quality of Life in Rare Kidney Stone Questionnaire']}], 'interventions': [{'name': 'Health-related Quality of Life in Rare Kidney Stone Questionnaire', 'type': 'OTHER', 'armGroupLabels': ['APRT deficiency', 'Cystinuria', 'Dent Disease', 'Primary Hyperoxaluria']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Primary Hyperoxaluria and Dent Disease Registry - Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '1001+', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University School of Medicine - Cystinuria Registry', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Reykjavik', 'country': 'Iceland', 'facility': 'APRT Registry - Landspitali Universtiy Hospital', 'geoPoint': {'lat': 64.13548, 'lon': -21.89541}}], 'overallOfficials': [{'name': 'David Goldfarb, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}