Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2026-03-12 @ 5:54 PM
Study NCT ID:
NCT03748693
Status:
UNKNOWN
Last Update Posted:
2018-11-21
First Post:
2018-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inflammation and Cellular Immunity in Vaginal Tissue in Patients With Pelvic Organ Prolapse
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}], 'ancestors': [{'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007044', 'term': 'Hysterectomy'}], 'ancestors': [{'id': 'D013509', 'term': 'Gynecologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-19', 'studyFirstSubmitDate': '2018-11-19', 'studyFirstSubmitQcDate': '2018-11-19', 'lastUpdatePostDateStruct': {'date': '2018-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immune response in POP', 'timeFrame': 'Two weeks', 'description': 'Tissue biopsy will analyzed for IMC and compared to control group'}, {'measure': 'Cytokine environment in POP', 'timeFrame': 'Two weeks', 'description': 'Tissue biopsy will analyzed for cytokine environment and compared to control group'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pelvic Organ Prolapse']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the inflammatory and maturation processes of immature myeloid cells (IMC) in the vaginal tissue in women with advanced pelvic organ prolapse (POP) (stage III-IV) and in normal non-POP controls.\n\nWe hypothesize that the processes contributing to POP may be related to immune response and changes in myeloid cell populations and the cytokine environment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women attending our OB/GYN department because of POP and other gynecological disorders', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with POP undergoing colporrhaphy\n* Women undergoing hysterectomy\n\nExclusion Criteria:\n\n* Autoimmune and connective tissue disorders\n* Cancer in genital tract'}, 'identificationModule': {'nctId': 'NCT03748693', 'briefTitle': 'Inflammation and Cellular Immunity in Vaginal Tissue in Patients With Pelvic Organ Prolapse', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'officialTitle': 'Inflammation and Cellular Immunity in Vaginal Tissue in Patients With Pelvic Organ Prolapse', 'orgStudyIdInfo': {'id': 'HYMC-0073-18'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'POP Group', 'description': 'Women with POP undergoing surgery in our OB/GYN department.', 'interventionNames': ['Procedure: Colporrhaphy']}, {'label': 'Non-POP Group', 'description': 'Women undergoing hysterectomy for other indications.', 'interventionNames': ['Procedure: Hysterectomy']}], 'interventions': [{'name': 'Hysterectomy', 'type': 'PROCEDURE', 'description': 'Surgery performed on women with a variety of gynecological indications', 'armGroupLabels': ['Non-POP Group']}, {'name': 'Colporrhaphy', 'type': 'PROCEDURE', 'description': 'Surgery performed on women with POP', 'armGroupLabels': ['POP Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mariana Ordonez, MD', 'role': 'CONTACT', 'email': 'malo_mariana@hotmail.com', 'phone': '972-52-3243474'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}