Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-01-26 @ 7:42 PM
Study NCT ID:
NCT02203318
Status:
COMPLETED
Last Update Posted:
2016-11-01
First Post:
2014-07-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Can the Hypertrophy of Contralateral Testis Predict the Absence of the Non-palpable Testis in the Boys Aged From 6months to 18months of Age ?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003456', 'term': 'Cryptorchidism'}], 'ancestors': [{'id': 'D013733', 'term': 'Testicular Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D014564', 'term': 'Urogenital Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-31', 'studyFirstSubmitDate': '2014-07-27', 'studyFirstSubmitQcDate': '2014-07-28', 'lastUpdatePostDateStruct': {'date': '2016-11-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Size of contralateral testis', 'timeFrame': '1 day of initial visit', 'description': 'The testicular size is measured 3-dimensionally with ultrasonography. The length, width and height will be measured and the volume of testis will be evaluated.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cryptorchidism, undescended testis, hypertrophy of contralateral testis'], 'conditions': ['Focus of Study']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to verify whether the hypertrophy of contralateral testis may predict the absence of the non-palpable testis in the boys younger than 24months of age. According to the previous studies of other countries, the large size of the contralateral testis of the nonpalpable testis has positive correlation woth the weak viability of the affected testis. We are going to evaluate this hypothesis with prospective study. 3 groups are going to be enrolled into this study ; non-palpable testis group(Group1), palpable but not normally descended testis group(group2) and control group(group3). The size of testis will be measured with Ultrasound and the length, width and the height will be measured before surgery at outpatient department. For the group 1 \\& 2, the viability of the affected testis will be evaluated and compared after surgery. In addition the comparison with normal control group is also going th be conducted.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '18 Months', 'minimumAge': '6 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'totally, 72 children : unpalpable testis : 24 children, palpable undescended testis : 24 children, normal control : 24 children', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. neonates or Infants who visited the out-patient clinic with nonpalpable or undescended testis.(group 1, 2) aged from 6months to 18months\n2. neonates or Infants aged from 6months to 18months with normal testis (volunteers, Group3)\n\nExclusion Criteria:\n\n1. previous history of hormonal therapy.\n2. chromosomal abnormality\n3. previous history of abdomen or inguinal area surgery\n4. children diagnosed with epididymitis or orchitis\n5. twin baby\n6. infants with premature (\\<37 weeks) birth history'}, 'identificationModule': {'nctId': 'NCT02203318', 'briefTitle': 'Can the Hypertrophy of Contralateral Testis Predict the Absence of the Non-palpable Testis in the Boys Aged From 6months to 18months of Age ?', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2014-0385'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'control', 'description': 'healthy children with normal bilateral testis'}, {'label': 'undescended palpable testis', 'description': 'patient whose affected testis is not descended to the normal position but palpable and exist intact in the upper area'}, {'label': 'non-paplpable testis', 'description': 'patient whose affected testis is not palpable during the physical examination'}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital, Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}