Ignite Creation Date:
2025-12-24 @ 7:30 PM
Ignite Modification Date:
2025-12-25 @ 5:11 PM
Study NCT ID:
NCT04755803
Status:
COMPLETED
Last Update Posted:
2023-05-06
First Post:
2021-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Prospective Registry of Patients With Congenital Penile Anomalies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007021', 'term': 'Hypospadias'}, {'id': 'D010688', 'term': 'Phimosis'}], '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Dartos Fascia is commonly known as subcutaneous tissue of the penis. It is located under the foreskin and superficially located on the outer external spermatic fascia of the scrotum and the axis of the penis. The primary role of dartos fascia is the mobility of the foreskin in the basal tissue and the blood supply from the external sinus vessels. Furthermore, it promotes heat loss and cools down the testicles.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-03', 'studyFirstSubmitDate': '2021-02-09', 'studyFirstSubmitQcDate': '2021-02-15', 'lastUpdatePostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dartos Fascia (Penile Tissue) sample collection', 'timeFrame': 'Procedure (At the time of penoplasty)', 'description': 'Collection of biological samples from pediatric patients who have been registered onto the prospective registry.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Concealed Penis', 'Hypospadias', 'Phimosis', 'Chordee']}, 'descriptionModule': {'briefSummary': 'Prospective registry and biobank in pediatric patients with congenital penile anomalies', 'detailedDescription': 'According to the U.S. Center for Disease Control and Prevention, in the United States, one in 200 babies is born with congenital penile anomalies. In Korea, there is a rapid increase rate among other types of congenital anomalies from 1993 to 2010, from 0.7 to 10,000 to 9.9 per 10,000 cases. It leaves long term sequelae into adulthood even after the corrective operation has been performed. Some of the sequelae that patients experienced were difficulties in micturition, dissatisfaction with the appearance of the penis, and decreased sexual function, as well as psychosexual well-being.\n\nDespite its high prevalence, hypospadias and related penile anomalies have no specific known etiology and mechanisms. However, numerous studies have shown that both gene and environment play a significant role in making etiologies multifactorial. Furthermore, a molecular trial shows that both genetics and environmental factors disrupt the normal development course of the phallus, or penis. Penis formation, growth, or the formation of the male urogenital system, in general, have shown to be androgen dependent. Any defect in the androgen synthesis leading to androgen deficiency or receptors may play a role, specifically, in the development of penile anomalies.\n\nPediatric patients between the ages of 0 to 18 years, with congenital penile anomalies and scheduled to undergo penoplasty will be enrolled. In this prospective observational study, our aims are to collect dartos fascia, which is a tissue in penile region, and examine histochemistry of the sample.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '0 Months', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male patients between the ages of 0 to 18 years with congenital penile anomalies and receiving penoplasty at the institution.', 'genderDescription': 'This registry is gender-specific and only males with congenital penile anomalies and receiving penoplasty at the institution are allowed to be enrolled.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Those with congenital penile anomalies (e.g. hypospadias, chordee, webbed penis) and receiving penoplasty at the institution.\n* Those who understand the registry's content and are signed and dated by the patient (or the patient's legal guardian or representative).\n\nExclusion Criteria:\n\n* Those who are unwilling to participate and do not sign the informed consent.\n* Unable to read or understand Korean."}, 'identificationModule': {'nctId': 'NCT04755803', 'briefTitle': 'A Prospective Registry of Patients With Congenital Penile Anomalies', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'A Prospective Registry of Patients With Congenital Penile Anomalies', 'orgStudyIdInfo': {'id': '2008-057-1147'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Penoplasty', 'type': 'PROCEDURE', 'description': 'Modified penoplasty technique:\n\n1. Degloved the penile skin and excise the inner prepuce.\n2. Advanced penoscrotal skin to cover penile shaft\n3. Fixed the penis base and reconstructed the penoscrotal angle'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Kwanjin Park', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}