Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2026-02-20 @ 1:34 PM
Study NCT ID:
NCT04012632
Status:
COMPLETED
Last Update Posted:
2019-07-11
First Post:
2019-07-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Kisspeptin/GPR54 Pathway and Early Puberty
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': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 628}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-07-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-09', 'studyFirstSubmitDate': '2019-07-05', 'studyFirstSubmitQcDate': '2019-07-05', 'lastUpdatePostDateStruct': {'date': '2019-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the polymorphism in the KISS1/GPR54 pathway genes', 'timeFrame': '3 months', 'description': 'functional SNP loci of the KISS1/GPR54 pathway genes KISS1, KISSIR, PLCB1, PRKCA, and ITPR1 were selected and detected.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SNP', 'kisspeptin', 'GPR54'], 'conditions': ['Puberty, Precocious']}, 'referencesModule': {'references': [{'pmid': '32160304', 'type': 'DERIVED', 'citation': 'Li D, Wu Y, Cheng J, Liu L, Li X, Chen D, Huang S, Wen Y, Ke Y, Yao Y, Su Z, Zhou L. Association of Polymorphisms in the Kisspeptin/GPR54 Pathway Genes With Risk of Early Puberty in Chinese Girls. J Clin Endocrinol Metab. 2020 Apr 1;105(4):dgz229. doi: 10.1210/clinem/dgz229.'}]}, 'descriptionModule': {'briefSummary': "There was a worldwide early trend in girls'age for puberty onset. The timing of puberty onset varies greatly among individuals, and much of this variation is modulated by genetic factors. This study was designed to explored the association of polymorphisms in KISS1/GPR54 pathway genes and the risk of early puberty in Chinese Han girls."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '7 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Chinese Han girls from Shenzhen Children's Hospital or monitoring schools in Shenzhen", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Clinical diagnosis of central precocious puberty or early and fast puberty.\n\nExclusion Criteria:\n\n* The participants who were not the first visit to the hospital and had been treated before.\n* The participants who were with endocrine disorders.'}, 'identificationModule': {'nctId': 'NCT04012632', 'briefTitle': 'Kisspeptin/GPR54 Pathway and Early Puberty', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Shenzhen Center for Disease Control and Prevention'}, 'officialTitle': 'Polymorphisms in the Kisspeptin/GPR54 Pathway Genes and the Risk of Early Puberty', 'orgStudyIdInfo': {'id': 'szCDC_1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'cases', 'description': 'Early puberty cases of Han Chinese'}, {'label': 'controls', 'description': 'Controls were matched to cases at 1:1 by age (± 3 months)', 'interventionNames': ['Other: this study was an observational study and no interventions were given to the participants']}], 'interventions': [{'name': 'this study was an observational study and no interventions were given to the participants', 'type': 'OTHER', 'description': 'the participants were recruited and the data as well as blood sample were collected.', 'armGroupLabels': ['controls']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shenzhen Center for Disease Control and Prevention', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Di Li', 'investigatorAffiliation': 'Shenzhen Center for Disease Control and Prevention'}}}}