Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-01-03 @ 8:35 AM
Study NCT ID:
NCT03838458
Status:
COMPLETED
Last Update Posted:
2020-04-28
First Post:
2019-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Molecular and Structural Comparison of Hypospadic and Normal Children Prepuces
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007021', 'term': 'Hypospadias'}, {'id': 'D003966', 'term': 'Camurati-Engelmann Syndrome'}], 'ancestors': [{'id': 'D014564', 'term': 'Urogenital Abnormalities'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D010409', 'term': 'Penile Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D010009', 'term': 'Osteochondrodysplasias'}, {'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Preputial tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-25', 'studyFirstSubmitDate': '2019-02-08', 'studyFirstSubmitQcDate': '2019-02-09', 'lastUpdatePostDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Genetic analysis 1', 'timeFrame': '1 year', 'description': 'Androgen receptor (AR) gene PCR analysis'}, {'measure': 'Genetic analysis 2', 'timeFrame': '1 year', 'description': 'Estrogen receptor 1 (ER1) gene PCR analysis'}, {'measure': 'Genetic analysis 3', 'timeFrame': '1 year', 'description': 'FGFR2 gene PCR analysis'}, {'measure': 'Genetic analysis 4', 'timeFrame': '1 year', 'description': 'TGF beta gene PCR analysis'}, {'measure': 'Genetic analysis 5', 'timeFrame': '1 year', 'description': 'HOXA13 gene PCR analysis'}, {'measure': 'Immunohistochemical study 1', 'timeFrame': '1 year', 'description': 'Mucosal vessel density is planned to determine via CD34'}, {'measure': 'Immunohistochemical study 2', 'timeFrame': '1 year', 'description': 'Mucosal nerve density is planned to determine via PGP 9.5'}, {'measure': 'Histological study 1', 'timeFrame': '1 year', 'description': 'Laminin is planned to determine in extracellular matrix via light microscope'}, {'measure': 'Histological study 2', 'timeFrame': '1 year', 'description': 'Collagen is planned to determine in extracellular matrix via light microscope'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hypospadias', 'prepuce', 'HOXA13', 'FGFR2', 'TGF beta'], 'conditions': ['Hypospadias']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare prepuce tissue samples from healthy male children who applied for circumcision and children with isolated hypospadias. Estrogen receptor 1 (ER1), androgen receptor (AR), FGFR2, transforming growth factor beta (TGF beta) and HOXA13 gene expression in the prepuce is planned to investigate via polymerase chain reaction (PCR) method. Mucosal vascular and nerve densities, and extracellular matrix density of laminin and collagen protein is planned to investigate via immunohistochemical examination.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '0-18 years old pediatric male population, patients with isolated hypospadias are study group, patients with planned circumcision are control group.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* To apply for circumcision, not to have any genitourinary abnormalities/conditions for control group.\n* To have isolated hypospadias for study group.\n\nExclusion Criteria:\n\n* To have genitourinary surgery before.'}, 'identificationModule': {'nctId': 'NCT03838458', 'briefTitle': 'Molecular and Structural Comparison of Hypospadic and Normal Children Prepuces', 'organization': {'class': 'OTHER', 'fullName': 'Trakya University'}, 'officialTitle': "Comparison of Structural and Molecular Genetic Properties Between Normal and Hypospadic Children's Prepuces", 'orgStudyIdInfo': {'id': 'Hypospadic prepuce structure'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study', 'description': 'Children with isolated hypospadias'}, {'label': 'Control', 'description': 'Children with planned circumcision'}]}, 'contactsLocationsModule': {'locations': [{'zip': '22030', 'city': 'Edirne', 'country': 'Turkey (Türkiye)', 'facility': 'Trakya University Faculty of Medicine', 'geoPoint': {'lat': 41.67719, 'lon': 26.55597}}], 'overallOfficials': [{'name': 'Dincer Avlan, Profesor, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Trakya University Faculty of Medicine, Pediatric Surgery Department'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Trakya University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Irem Inanc', 'investigatorAffiliation': 'Trakya University'}}}}