Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2026-01-03 @ 8:39 PM
Study NCT ID:
NCT02950350
Status:
UNKNOWN
Last Update Posted:
2016-11-01
First Post:
2016-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial of Laparoscopic Pelvic and Para-aortic Lymphadenectomy and Uterine Blood Vessel Blocking for Precision Diagnosis and Treatment in Advanced 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-31', 'studyFirstSubmitDate': '2016-10-28', 'studyFirstSubmitQcDate': '2016-10-31', 'lastUpdatePostDateStruct': {'date': '2016-11-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The recurrence rate', 'timeFrame': '5 years after treatment'}], 'secondaryOutcomes': [{'measure': 'The transfer rate', 'timeFrame': '5 years after treatment'}, {'measure': 'mortality', 'timeFrame': '5 years after treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cervical cancer', 'Precision medicine', 'Individualized treatment', 'Surgical staging'], 'conditions': ['Cervical Cancer, Stage IIB', 'Cervical Cancer Stage IIIA', 'Cervical Cancer Stage IIIB', 'Cervical Cancer, Stage IVA']}, 'descriptionModule': {'briefSummary': 'Cervical cancer is the most common reproductive malignancy in developing country. Due to local invasion, radical hysterectomy cannot be performed in advanced cervical cancer (FIGO IIB - IVA) , so that radiation combined with chemoradiation (RCTX) is a traditional treatment nowadays. Lack of precise treatment strategies, recurrent ratesand metastasisis high ,and the 5-year survival rate is less than 50%. Therefore, it needs to explore a new strategy for improving the prognosis of advanced cervical cancer.\n\nThe prognosis of cervical cancer is closely related to its stages ,while the current FIGO clinical stage is too subjective , for example different gynecologic oncologists may give different diagnosis to the same patient. MRI, CT, PET/CT imaging examinations are commonly used as a referrence for clinical staging, but the sensitivity and specificity are not satisfied. In addition, lymph node metastasis significantly impacts the prognosis of cervical cancer . However, the lymph node invasion is not in current staging criteria.\n\nPrecision treatment after surgical staging is recommended by NCCN recently .Surgical staging in patients with advancedcervical cancer is safe and does not delay primary RCTX in few randomized study.Whether overall survival benefit the long-term clinical follow-up surgical staging is unknown.Blocking bilateral uterine artery can effectively reduce the tumor size and increase the operability , which has been conformed in locally advanced cervical cancer. Furthermore, ovarian dysfunction caused by RCTX could be avoided by ovarian transposition via surgical staging .\n\nBased on this, we suggesta new surgical stagingfor patients with advanced cervical cancer , which includinglaparoscopic pelvic and para-aortic lymphadenectomy , uterine blood vessel blocking and ovarian transportation, in order to perform individualized postoperative RCTX, reduce tumor load , preserve ovarian function and improve life quality.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients from Dec 2016 until Dec 2018 in Shanghai First Maternity and Infant Hospital, Tongji University.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathological diagnosis: squamous carcinoma, adenocarcinoma, adenosquamous carcinoma\n* The pathological staging:IIB,IIIA,IIIB,IVA\n\nExclusion Criteria:\n\n* Underwent surgery or radiation and chemotherapy'}, 'identificationModule': {'nctId': 'NCT02950350', 'briefTitle': 'Clinical Trial of Laparoscopic Pelvic and Para-aortic Lymphadenectomy and Uterine Blood Vessel Blocking for Precision Diagnosis and Treatment in Advanced Cervical Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai First Maternity and Infant Hospital'}, 'officialTitle': 'Clinical Trial of Laparoscopic Pelvic and Para-aortic Lymphadenectomy and Uterine Blood Vessel Blocking for Precision Diagnosis and Treatment in Advanced Cervical Cancer', 'orgStudyIdInfo': {'id': 'Guo Xiaoqing'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'radiation and chemotherapy', 'description': 'The patients will receive radiation and chemotherapy'}, {'label': 'removal of pelvic lymph nodes and abdominal aorta lymph nodes', 'description': 'The patients will receive removal of pelvic lymph nodes and abdominal aorta lymph nodes ,and receive concurrent radiation and chemotherapy'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Xiaoqing Guo, PHD', 'role': 'CONTACT', 'email': 'xiaoqingguo333@163.com', 'phone': '18117203488'}, {'name': 'Na Liu, PHD', 'role': 'CONTACT', 'email': '1517693296@qq.com', 'phone': '15601745699'}], 'overallOfficials': [{'name': 'Xiaoqing Guo, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai First Maternity and Infant Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': "we need get the patients' agreement to share data."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai First Maternity and Infant Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}