Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT05310318
Status:
UNKNOWN
Last Update Posted:
2022-04-04
First Post:
2022-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prognosis of Low-grade Endometrial Stromal Sarcoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D036821', 'term': 'Endometrial Stromal Tumors'}, {'id': 'D004194', 'term': 'Disease'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'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': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2025-03-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-26', 'studyFirstSubmitDate': '2022-03-26', 'studyFirstSubmitQcDate': '2022-03-26', 'lastUpdatePostDateStruct': {'date': '2022-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'One year', 'description': 'Progression-free survival after surgery'}, {'measure': 'Overall survival', 'timeFrame': 'One year', 'description': 'Overall survival after surgery'}, {'measure': 'Pregnancy rate', 'timeFrame': 'One year', 'description': 'Pregnancy rate after surgery in patients with fertility-sparing patients'}], 'secondaryOutcomes': [{'measure': 'Miscarriage rate', 'timeFrame': 'One year', 'description': 'Miscarriage rate after surgery in patients with fertility-sparing patients'}, {'measure': 'Full-term pregnancy rate', 'timeFrame': 'One year', 'description': 'Full-term pregnancy rate after surgery in patients with fertility-sparing patients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Low Grade Endometrial Stromal Sarcoma of Uterus (Diagnosis)', 'Fertility-sparing Surgery', 'Survival Outcomes', 'Fertility Outcomes', 'Recurrence', 'Hormone Therapy', 'Adjuvant Therapy']}, 'descriptionModule': {'briefSummary': 'This study is to investigate the survival outcomes and fertility outcomes in patients with uterine low-grade endometrial stromal sarcoma (LGESS) treated in Peking Union Medical College Hospital. All primary and recurrent LGESS patients will be enrolled. The study will collect retrospectively data consisting of epidemiological characteristics, surgical, medical treatment and adjuvant therapy. Details about recurrence, mortality, pregnancy and obstetrical outcomes are also followed as primary endpoints. Fertility-sparing procedures, including uterine-sparing and ovary-sparing surgeries will be recorded specifically.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients accepted surgical treatment with and without fertility-sparing procedures for uterine low-grade endometrial stromal sarcoma.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 years or older\n* Confirmed of LGESS\n* Acceptance of surgical treatment for LGESS\n* With detailed follow-up outcomes\n\nExclusion Criteria:\n\n\\- Not meeting all of the inclusion criteria'}, 'identificationModule': {'nctId': 'NCT05310318', 'briefTitle': 'Prognosis of Low-grade Endometrial Stromal Sarcoma', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Surgical and Reproductive Results of Fertility-sparing Treatment for Low-grade Endometrial Stromal Sarcoma: A Retrospective Cohort Study', 'orgStudyIdInfo': {'id': 'SOUM-2'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Surgical treatment with and without fertility-sparing procedures', 'type': 'PROCEDURE', 'otherNames': ['Adjuvant therapy after surgery'], 'description': 'Patients accepted surgeries for LGESS and relevant adjuvant therapy if indicated.'}]}, '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': '008613911988831'}], 'facility': 'Lei Li', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Lei Li, M.D.', 'role': 'CONTACT', 'email': 'lileigh@163.com', 'phone': '86-139-1198-8831'}], 'overallOfficials': [{'name': 'Lei Li, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lei Li', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Lei Li', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}