Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2026-03-02 @ 4:23 PM
Study NCT ID:
NCT06533306
Status:
COMPLETED
Last Update Posted:
2024-08-01
First Post:
2024-07-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metachronous Acquired Contralateral Cryptorchidism in Patients With a History of Unilateral Cryptorchidism.
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-29', 'studyFirstSubmitDate': '2024-07-25', 'studyFirstSubmitQcDate': '2024-07-29', 'lastUpdatePostDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Contralateral Cryptorchidism', 'timeFrame': 'Up to 1 month', 'description': 'Proportion of patients previously operated on for cryptorchidism in whom acquired contralateral cryptorchidism is detected.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cryptorchidism'], 'conditions': ['Cryptorchidism']}, 'descriptionModule': {'briefSummary': 'The present study aims to calculate the risk of a patient with a history of cryptorchidism developing cryptorchidism on the contralateral side.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients previously operated on for cryptorchidism', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 13 years or older, previously operated on for cryptorchidism.\n\nExclusion Criteria:\n\n* Diagnosis of endocrine disease or any polymalformative syndrome.\n* Synchronous bilateral cryptorchidism.'}, 'identificationModule': {'nctId': 'NCT06533306', 'briefTitle': 'Metachronous Acquired Contralateral Cryptorchidism in Patients With a History of Unilateral Cryptorchidism.', 'organization': {'class': 'OTHER', 'fullName': "Consorci Sanitari de l'Alt Penedès i Garraf"}, 'officialTitle': 'Estimation of the Risk of Presenting Metachronous Acquired Contralateral Cryptorchidism in Patients With a History of Unilateral Cryptorchidism.', 'orgStudyIdInfo': {'id': 'CSAPG-63'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Surgery for cryptorchidism.', 'type': 'PROCEDURE', 'description': 'Patients previously operated on for cryptorchidism.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08720', 'city': 'Vilafranca del Penedès', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Consorci Sanitari Alt Penedès-Garraf', 'geoPoint': {'lat': 41.34618, 'lon': 1.69713}}], 'overallOfficials': [{'name': 'Carme Grande Moreillo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CSAPG'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After publication of main results of the study.', 'ipdSharing': 'YES', 'description': 'IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).', 'accessCriteria': 'IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Consorci Sanitari de l'Alt Penedès i Garraf", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}