Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-01-06 @ 5:52 AM
Study NCT ID:
NCT06520969
Status:
RECRUITING
Last Update Posted:
2024-07-25
First Post:
2024-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevelance of Uterine Vein and Uterine Vein System Variations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Endometrium and cervical cancer patients that will be operated in Istanbul University School of Medicine, Dept. of Obstetrics and Gynecology, Division of Oncology will be included. Anatomic details such as the presence, number of superficial and deep uterine veins, calibers, anatomical relationships with hypogastric arteries and veins, ureters, vesicouterine ligaments will be described systematically and bilaterally for every consenting women after pelvic spaces are opened before pelvic lypmhadenectomy and hysterectomy. All regarding information will be photographed for every patient bilaterally and recorded on data sheet.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2027-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-20', 'studyFirstSubmitDate': '2024-07-20', 'studyFirstSubmitQcDate': '2024-07-20', 'lastUpdatePostDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To describe the prevalence of uterine vein and uterine vein system variations', 'timeFrame': '2 years', 'description': 'To describe the prevalence of uterine vein and uterine vein system variations'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Uterine Vein Injury Left', 'Uterine Vein Injury Right']}, 'descriptionModule': {'briefSummary': 'Contrary to the uterine arterial system, our knowledge about superficial and deep uterine vein prevalence and anatomic variations are limited. The present study aims to deepen and clarify our knowledge on superficial and deep uterine vein anatomy, prevalence and relationship with other neighbouring structures which may be helpful in uterine transplantation and radical hysterectomy operations.', 'detailedDescription': 'Despite that two veins draining the uterus, superficial and deep, are described, their true anatomy, number, calibers, trajectories, relationships with sympathetic and parasympathetic nerves and internal iliac vasculature and ureters are quite limited. Additionally, variations of these vasculature are much less described. The aim of this study is to increase the our current knowledge about these anatomical information and also to calculate the prevalence of superficial and deep uterine veins which may potentially decrease the possible complications such as bleeding in uterine transplantation surgery and nerve sparing radical hysterectomy for cervical cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'genderDescription': 'Endometrium and cervical cancer patients that will be operated', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nEndometrium and cervical cancer patients that will be operated -\n\nExclusion Criteria:\n\nAny women in whom uterine vascular anatomy that might be changed for a specific disease such as myomas, uterine infections, etc.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06520969', 'briefTitle': 'Prevelance of Uterine Vein and Uterine Vein System Variations', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'Prevelance of Uterine Vein and Uterine Vein System Variations', 'orgStudyIdInfo': {'id': '2248661'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'prevalance and anatomical variations of superficial and deep veins', 'description': 'Single arm anatomical study describing the prevalance and anatomical variations of superficial and deep veins in endometrial and cervical cancer patients', 'interventionNames': ['Other: Prevelance of Uterine Vein and Uterine Vein System Variations (anatomical study)']}], 'interventions': [{'name': 'Prevelance of Uterine Vein and Uterine Vein System Variations (anatomical study)', 'type': 'OTHER', 'otherNames': ['Single arm anatomical study describing the prevalance and anatomical variations of superficial and deep veins in endometrial and cervical cancer patients'], 'description': 'Single arm anatomical study describing the prevalance and anatomical variations of superficial and deep veins in endometrial and cervical cancer patients', 'armGroupLabels': ['prevalance and anatomical variations of superficial and deep veins']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34093', 'city': 'Istanbul', 'state': 'Istanbul / Turkey', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Mustafa ALBAYRAK, MD', 'role': 'CONTACT', 'email': 'mustafaalbayrak@icloud.com', 'phone': '+905326871051'}, {'name': 'Yagmur MINARECI, MD', 'role': 'CONTACT', 'email': 'yagmurminareci@gmail.com', 'phone': '+905053574361'}], 'facility': 'Istanbul University Medical Faculty Dept. of Obstet Gynecol, Division of Gynecologic Oncology', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Mustafa ALBAYRAK, MD', 'role': 'CONTACT', 'email': 'mustafaalbayrak@icloud.com', 'phone': '+90 532 687 10 51'}, {'name': 'Atahan TOYRAN, MD', 'role': 'CONTACT', 'email': 'atahantoyran@hotmail.com', 'phone': '+90 505 714 62 33'}], 'overallOfficials': [{'name': 'Samet Topuz, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Istanbul Univrsity'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'no time frame limit, all open for all times', 'ipdSharing': 'YES', 'description': 'all information stated in this document is open to to third parties whitout any limitations'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Gynecologic Oncology Fellow', 'investigatorFullName': 'Mustafa Albayrak', 'investigatorAffiliation': 'Istanbul University'}}}}