Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2026-03-07 @ 11:03 PM
Study NCT ID:
NCT01893333
Status:
UNKNOWN
Last Update Posted:
2017-05-31
First Post:
2013-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy and Safety of Nerve-sparing Radical Hysterectomy in Cervical Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 146}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-27', 'studyFirstSubmitDate': '2013-06-10', 'studyFirstSubmitQcDate': '2013-07-02', 'lastUpdatePostDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of bladder dysfunction after surgery', 'timeFrame': '5 days after the surgery', 'description': 'Remove foley catheter and measure the residual urine volume Measure how long it took to be residual urine volume under 50 mL'}], 'secondaryOutcomes': [{'measure': 'rectal & anal function after surgery', 'timeFrame': '6, 12 months after surgery'}, {'measure': 'Sexual function', 'timeFrame': '6, 12 months after surgery'}, {'measure': 'Quality of life', 'timeFrame': '6, 12 months after surgery'}, {'measure': 'operative time', 'timeFrame': 'immediately after surgery'}, {'measure': 'amount of bleeding in operation', 'timeFrame': 'immediately after surgery'}, {'measure': 'frequency of blood transfusion', 'timeFrame': 'within 1 week after surgery'}, {'measure': 'amount of blood transfusion', 'timeFrame': 'within 1 week after surgery'}, {'measure': 'postoperative complication', 'timeFrame': 'within 1 month after surgery'}, {'measure': 'time from surgery to return to work', 'timeFrame': 'within 1 month after surgery'}, {'measure': 'management cost', 'timeFrame': 'within 1 week after surgery'}, {'measure': 'size of resected parametrial tissue', 'timeFrame': 'immediately after surgery'}, {'measure': '2year disease free survival', 'timeFrame': '2 year after treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cervical cancer', 'nerve sparing radical hysterectomy'], 'conditions': ['Cervical Cancer']}, 'descriptionModule': {'briefSummary': 'To develope nerve sparing radical hysterectomy for treatment of cervical cancer to minimize the complication of radical hysterectomy and to maximize quality of life and to evaluate the feasibility and efficacy by prospective randomized trial.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically diagnosed cervical cancer\n* FIGO stage IA2-IIA\n* Diameter of tumor is less than 4cm on exam\n* One of hitological type written below squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma\n* Age between 18-70\n* Performance status; GOG 0-1\n* Normal hematological, hepatic, nephrologic function WBC ≥ 4000 cells/mm3 Platelet ≥ 100,000 /mm3 Hemoglobin ≥ 8.0 gm/dL Serum creatinin ≤ 1.3 mg/dL Serum bilirubin ≤ 1.5 mg/dL SBOT/SGPT and Alkaline phoaphatase \\< normal X 3\n* Patient with informed consent\n\nExclusion creteria:\n\n* Small cell carcinoma\n* Unable to perform surgery because of severe underlying medical disease severe heart disease, congestive heart failure/severe pulmonary disease, pulmonary failure/ active bacterial infectio which needs non oral antibiotic therapy/ associated with other severe medical diseases\n* Prior chemotherapy or radiotherapy\n* Severe bladder funtion abnormality\n* Double primary malignant tumor\n* Psychiatric problems\n* Pregnant or breast feeding status\n* Legally unable to participate clinical trial\n* When there is a Doctor's decision that patient is unable to participate clinical trial"}, 'identificationModule': {'nctId': 'NCT01893333', 'acronym': 'NSRHCXCA', 'briefTitle': 'The Efficacy and Safety of Nerve-sparing Radical Hysterectomy in Cervical Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'The Efficacy and Safety of Nerve-sparing Radical Hysterectomy in Cervical Cancer', 'orgStudyIdInfo': {'id': 'NSRH_Cxca'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nerve sparing radical hysterectomy group', 'description': '1. sparing hypogastric nerve\n2. sparing pelvic splanchnic nerve ad pelvic plexus in cardinal ligament\n3. sparing distal part of hypogastric nerve and vesical branch of pelvic splanchnic nerve', 'interventionNames': ['Procedure: Nerve sparing radical hysterectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Radical hysterectomy group', 'description': 'Conventional radical hysterectomy', 'interventionNames': ['Procedure: Nerve sparing radical hysterectomy']}], 'interventions': [{'name': 'Nerve sparing radical hysterectomy', 'type': 'PROCEDURE', 'description': 'Nerve sparing radical hysterectomy\n\n1. sparing hypogastric nerve\n2. sparing pelvic splanchnic nerve ad pelvic plexus in cardinal ligament\n3. sparing distal part of hypogastric nerve and vesical branch of pelvic splanchnic nerve', 'armGroupLabels': ['Nerve sparing radical hysterectomy group', 'Radical hysterectomy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '138-736', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Joo-Hyun Nam, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'jhnam@amc.seoul.kr', 'phone': '82-2-3010-3633'}], 'facility': 'Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Joo-Hyun Nam, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'jhnam@amc.seoul.kr', 'phone': '82-2-3010-3633'}], 'overallOfficials': [{'name': 'Joo-Hyun Nam, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Joo-Hyun Nam', 'investigatorAffiliation': 'Asan Medical Center'}}}}