Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2026-02-25 @ 8:16 PM
Study NCT ID:
NCT03738969
Status:
UNKNOWN
Last Update Posted:
2018-11-14
First Post:
2018-11-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Longitudinal Study of Different Surgical Approaches in Chinese Patients of Uterine Cervical Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D012008', 'term': 'Recurrence'}], '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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2023-12-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-09', 'studyFirstSubmitDate': '2018-11-08', 'studyFirstSubmitQcDate': '2018-11-08', 'lastUpdatePostDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pregnancy rate', 'timeFrame': 'Five years', 'description': 'Proportion of patients who have been pregnant after the fertility-preserving radical trachelectomy'}], 'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'Five years', 'description': 'Length of time during and after the treatment of cervical cancer, that a patient lives with the disease but it does not get worse'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'Five years', 'description': 'The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive. In a clinical trial, measuring the overall survival is one way to see how well a new treatment works.'}, {'measure': 'Disease-free survival', 'timeFrame': 'Five years', 'description': 'In cancer, the length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer. In a clinical trial, measuring the disease-free survival is one way to see how well a new treatment works.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Uterine Cervical Neoplasms', 'Laparotomy', 'Laparoscopy', 'Survival', 'Mortality', 'Recurrence']}, 'referencesModule': {'references': [{'pmid': '32819996', 'type': 'DERIVED', 'citation': 'Chao X, Wu M, Ma S, Tan X, Zhong S, Song X, Li L. Efficacy of different surgical approaches on survival outcomes in patients with early-stage cervical cancer: protocol for a multicentre longitudinal study in China. BMJ Open. 2020 Aug 20;10(8):e038020. doi: 10.1136/bmjopen-2020-038020.'}]}, 'descriptionModule': {'briefSummary': 'This multi-center longitudinal study aims to compare the survival outcomes (including overall survival, progression-free survival and disease-free survival between uterine cervical patients receiving different surgical routes (vaginal, laparotomy and laparoscopy), which is the primary study objective. All clinical and pathological data would be retracted from case reviews, and all survival data would be reached by clinic, telephone and mail follow-up. This study also would analyze the impact on survival outcomes of other factors, including nerve-sparing techniques, neoadjuvant chemotherapy, neoadjuvant radiotherapy and infection of human papillomavirus. The predictive effects of different following protocol and imaging plans will be also compared. Last, the influences of surgical routes on the fertility outcomes (pregnancy and its complications) and the ovarian reserve are important secondary study objectives.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients pathological confirmed as uterine cervival cancer and receiving radical hysterectomy or trachelectomy would been included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathological confirmed as uterine cervical cancer\n* Having definite clinical information\n* Having received radical hysterectomy or trachelectomy\n\nExclusion Criteria:\n\n* Not satisfying any of the inclusion criteria'}, 'identificationModule': {'nctId': 'NCT03738969', 'briefTitle': 'Longitudinal Study of Different Surgical Approaches in Chinese Patients of Uterine Cervical Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Longitudinal Study of Different Surgical Approaches in Chinese Patients of Cervical Cancer', 'orgStudyIdInfo': {'id': 'SACCC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Laparotomy group', 'description': 'Patients in this group accepted laparotomic radical hysterectomy for cervical cancer.', 'interventionNames': ['Procedure: Laparotomic radical hysterectomy']}, {'label': 'Laparoscopy group', 'description': 'Patients in this group accepted laparoscopic or robotic radical hysterectomy for cervical cancer.', 'interventionNames': ['Procedure: Laparoscopic radical hysterectomy']}], 'interventions': [{'name': 'Laparotomic radical hysterectomy', 'type': 'PROCEDURE', 'description': 'Radical hysterectomy applied by laparotomy', 'armGroupLabels': ['Laparotomy group']}, {'name': 'Laparoscopic radical hysterectomy', 'type': 'PROCEDURE', 'description': 'Radical hysterectomy applied by laparoscopic', 'armGroupLabels': ['Laparoscopy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lei Li, MD', 'role': 'CONTACT', 'email': 'lileigh@163.com', 'phone': '13911988831', 'phoneExt': '86'}], 'facility': 'Lei Li', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Lei Li, M.D.', 'role': 'CONTACT', 'email': 'lileigh@163.com', 'phone': '13911988831', 'phoneExt': '86'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'ipdSharing': 'YES', 'description': 'All the data will be available to all researchers on the public websites'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lei Li', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Lei Li', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}