Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:27 PM
Study NCT ID:
NCT06176469
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-11
First Post:
2023-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Renal Colic and Urolithiasis in Poland
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056844', 'term': 'Renal Colic'}, {'id': 'D052878', 'term': 'Urolithiasis'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-06-01', 'size': 812521, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-02-07T13:49', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-07', 'studyFirstSubmitDate': '2023-12-09', 'studyFirstSubmitQcDate': '2023-12-18', 'lastUpdatePostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of renal colic and urolithiasis in Poland', 'timeFrame': 'December 2023 - December 2024', 'description': 'Prevalence of renal colic and urolithiasis in Poland'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Renal Colic', 'Urolithiasis']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to analyze the prevalence, effect on quality of life, and treatment-related behaviors for renal colic and urolithiasis in a population-representative sample of Poles. We will be using an Internet interview format for renal colic and urolithiasis evaluation. The study will include respondents representative for age and place of residence with adequate proportions of respondents from urban and rural areas.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'A representative pool of men and women in Poland', 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- consent to participate\n\nExclusion Criteria:\n\n\\- lack of consent to participate'}, 'identificationModule': {'nctId': 'NCT06176469', 'acronym': 'POLSTONE', 'briefTitle': 'Renal Colic and Urolithiasis in Poland', 'organization': {'class': 'OTHER', 'fullName': 'Jagiellonian University'}, 'officialTitle': 'Population-level Prevalence, Effect on Quality of Life, and Treatment Behavior for Renal Colic and Urolithiasis in Poland', 'orgStudyIdInfo': {'id': '118.6120.94.2023'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Population-level and representative cohort', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['Population-level and representative cohort']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Krakow', 'country': 'Poland', 'facility': 'Department of Urology, Jagiellonian University', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mikolaj Przydacz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Mikolaj Przydacz', 'investigatorAffiliation': 'Jagiellonian University'}}}}