Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2025-12-25 @ 7:08 PM
Study NCT ID:
NCT03538704
Status:
UNKNOWN
Last Update Posted:
2018-05-29
First Post:
2018-03-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Fertility-sparing Therapy of Early Endometrial Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016889', 'term': 'Endometrial 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': '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-24', 'studyFirstSubmitDate': '2018-03-14', 'studyFirstSubmitQcDate': '2018-05-24', 'lastUpdatePostDateStruct': {'date': '2018-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Recurrence rate', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'Pathology shows atypical hyperplasia or carcinoma again after complete response.'}], 'primaryOutcomes': [{'measure': 'Complete response rate', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'Histologically shows absence of pathological hyperplasia or carcinoma.'}], 'secondaryOutcomes': [{'measure': 'Pregnancy rate', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'Pregnancy test shows pregnancy after complete response.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endometrial cancer', 'Atypical hyperplasia', 'Fertility-preserving', 'Remission time', 'Recurrence', 'Pregnancy', 'Progesterone receptor'], 'conditions': ['Endometrial Cancer', 'Fertility']}, 'referencesModule': {'references': [{'pmid': '23021687', 'type': 'RESULT', 'citation': 'Gallos ID, Yap J, Rajkhowa M, Luesley DM, Coomarasamy A, Gupta JK. Regression, relapse, and live birth rates with fertility-sparing therapy for endometrial cancer and atypical complex endometrial hyperplasia: a systematic review and metaanalysis. Am J Obstet Gynecol. 2012 Oct;207(4):266.e1-12. doi: 10.1016/j.ajog.2012.08.011. Epub 2012 Aug 10.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effect of Fertility-sparing Therapy of Early Endometrial Cancer.', 'detailedDescription': 'This is a prospective, multi center, open, randomized, controlled clinical trial. All endometrial cancer (EC) or atypical hyperplasia (AH) patients who met the fertility-sparing indications in the hospitals involved in this study were recruited. Then the investigators conducted assessment, treatment and follow up according to the standard procedure. General information, therapeutic regimen, side effects, oncological and pregnant results were collected for risk factors analysis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ages of no more than 40\n* with a strong desire of fertility preservation\n* International Federation of Gynecology and Obstetrics (FIGO) 2009 stage Ⅰa grade 1\\~2 with lesion confined in endometrium\n* pathology expression of progestin receptors (PRs) and estrogen receptors\n\nExclusion Criteria:\n\n* not eligible for pregnancy or delivery\n* evidence of suspected extrauterine or distant metastasis\n* complicated with any other malignancy\n* severe medical complications\n* contraindication of oral progestin\n* uncontrolled epilepsy, central nervous system disease or mental disorder history in patients which Influence clinical research compliance judging by the researcher.'}, 'identificationModule': {'nctId': 'NCT03538704', 'acronym': 'ECFerSp', 'briefTitle': 'Effect of Fertility-sparing Therapy of Early Endometrial Cancer', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'Effect of Fertility-sparing Therapy of Early Endometrial Cancer', 'orgStudyIdInfo': {'id': '2018ECFerSp'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BMI≥25 group with metformin', 'description': 'Patients with BMI≥25kg/m2 in the experimental group are treated with medroxyprogesterone acetate (MPA) 0.25g/d plus metformin and are followed-up of baseline data, hormone levels,', 'interventionNames': ['Drug: Metformin']}, {'type': 'NO_INTERVENTION', 'label': 'BMI≥25 group without metformin', 'description': 'Patients with BMI≥25kg/m2 in the none intervention group are treated with MPA 0.25g/d alone and are followed-up of baseline data, hormone levels, and endometrial pathology every 3 months until 12 months.'}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'description': 'Metformin is given to patients 1-1.5g/d.', 'armGroupLabels': ['BMI≥25 group with metformin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianliu Wang, Professor', 'role': 'CONTACT', 'email': 'wangjianliu1203@163.com', 'phone': '010-88324381'}], 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jianliu Wang, Professor', 'role': 'CONTACT', 'email': 'wangjianliu1203@163.com', 'phone': '010-88324381'}, {'name': 'Rong Zhou, Professor', 'role': 'CONTACT', 'email': 'zhourong@pku.edu.cn', 'phone': '010-88324350'}], 'overallOfficials': [{'name': 'Jianliu Wang, Professor', 'role': 'STUDY_CHAIR', 'affiliation': "Department of Obstetrics and Gynecology, Peking University People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Peking University First Hospital', 'class': 'OTHER'}, {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, {'name': 'Tianjin Medical University General Hospital', 'class': 'OTHER'}, {'name': 'Maternal and Child Health Hospital of Hubei Province', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, {'name': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}