Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-29 @ 5:59 PM
Study NCT ID:
NCT05341128
Status:
COMPLETED
Last Update Posted:
2025-09-02
First Post:
2022-04-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Medical Records From Children With Central Precocious Puberty (CPP) in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011629', 'term': 'Puberty, Precocious'}], 'ancestors': [{'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1477}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-08-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-29', 'studyFirstSubmitDate': '2022-04-18', 'studyFirstSubmitQcDate': '2022-04-21', 'lastUpdatePostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With CPP Treatment', 'timeFrame': 'Up to approximately 10 years'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With CPP Treatment at Baseline', 'timeFrame': 'At Baseline'}, {'measure': 'Percentage of Participants With Luteinizing hormone (LH) Suppression', 'timeFrame': 'Baseline up to approximately 10 years'}, {'measure': 'Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'Up to approximately 10 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Central Precocious Puberty'], 'conditions': ['Central Precocious Puberty']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicaltrials.takeda.com/study-detail/88f831d40d9d43b3?idFilter=%5B%22Leuprorelin-5007%22%5D', 'label': 'To obtain more information on the study, click on this link'}]}, 'descriptionModule': {'briefSummary': 'The main purpose is to describe how many children were treated during 24 months or less because of CPP and how treatment worked for them.\n\nThere are no participants in this trial, the study only involves reviewing participants medical past and current records and collecting information.', 'detailedDescription': 'This is an observational, non-interventional, retrospective study to evaluate the participants characteristics, current treatment patterns and resource usage in Chinese pediatric participants diagnosed with CPP.\n\nThis study will enroll approximately 1000 participants.\n\nThe data available in an existing data source the Chinese CPP Big Data Platform database will be analyzed. All the participants will be assigned to a single observational cohort:\n\n• Pediatric Participants With CPP\n\nThis multi-center trial will be conducted in China. The overall duration of the study will be approximately 3 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric participants with a diagnosis of CPP who are currently or previously undergoing GnRHa treatment between 2015 and 31 December 2024 will be enrolled in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Participants diagnosed with CPP and treated with GnRHa from the centers participating in this study within the Chinese CPP Big Data Platform database since 2015 to 2024.\n\nCPP diagnosis is based on the clinical assessment and description by CPP specialized doctors.\n\nExclusion Criteria:\n\n* Not received GnRHa as the treatment for CPP.\n* No available data for analysis.'}, 'identificationModule': {'nctId': 'NCT05341128', 'acronym': 'PACTURE', 'briefTitle': 'A Study of Medical Records From Children With Central Precocious Puberty (CPP) in China', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'Patient Characteristics, Treatment Patterns, and Resource Usage in Children Diagnosed With Central Precocious Puberty (CPP) in China', 'orgStudyIdInfo': {'id': 'Leuprorelin-5007'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All Participants With CPP', 'description': 'Pediatric participants who have been diagnosed with CPP, who are currently or previously undergoing with gonadotropin-releasing hormone agonist (GnRHa) treatment between 2015, and 31 December 2024 will be assessed retrospectively using the Chinese CPP Big Data Platform database.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '530007', 'city': 'Nanning', 'state': 'Guangxi', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Guangxi Medical University', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}, {'zip': '570206', 'city': 'Haikou', 'state': 'Hainan', 'country': 'China', 'facility': "Hainan Women and Children's Medical Center", 'geoPoint': {'lat': 20.03421, 'lon': 110.34651}}, {'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '250021', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Shandong Provincial Hospital Affiliated to Shandong First Medical University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '300052', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Tianjin Medical University General Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/takeda/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'ipdSharing': 'YES', 'description': "Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.", 'accessCriteria': 'IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}