Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2026-04-17 @ 7:51 AM
Study NCT ID:
NCT01830192
Status:
COMPLETED
Last Update Posted:
2013-04-12
First Post:
2013-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
REM (Risk Of Endometrial Malignancy)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}], 'ancestors': [{'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': '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 741}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-11', 'studyFirstSubmitDate': '2013-04-05', 'studyFirstSubmitQcDate': '2013-04-11', 'lastUpdatePostDateStruct': {'date': '2013-04-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'REM', 'timeFrame': '2 years', 'description': 'We consider training and verification set together to evaluate the overall sensitivity and specificity of predictive tool'}], 'primaryOutcomes': [{'measure': 'REM (RISK OF ENDOMETRIAL MALIGNANCY): a proposal for a new scoring system to evaluate risk of endometrial malignancy.', 'timeFrame': '2 year', 'description': 'We select patients affected by endometrial cancer and benign endometrial disease. Preoperative they underwent to pelvic ultrasound, CA125 and HE4 dosage and anamnesis. They will be considered as training group to obtaine the probability of endometrial malignancy based on HE4, ultrasound features and symptoms.'}], 'secondaryOutcomes': [{'measure': 'REM', 'timeFrame': '2 years', 'description': 'We select a verification set, composed by endometrial cancer disease and benign endometrial pathologies patients. In this set we apply the risk of endometrial cancer tool, obtained in the training set, in order to verify the sensitivity, specificity and reproducibility.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['endometrial cancer', 'score', 'nomogram', 'ultrasound', 'HE4'], 'conditions': ['Endometrial Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to obtain a predictive model to asses the Risk of Endometrial Malignancy (REM) in women with ultrasound endometrial abnormalities.', 'detailedDescription': 'Objective: It is often difficult to distinguish a benign endometrial disease from a malignancy and tools to help physician are needed, in order to triage patients into high and low risk of endometrial cancer (EC). The purpose of this study was to obtain a predictive model to asses the Risk of Endometrial Malignancy (REM) in women with ultrasound endometrial abnormalities.Women, between 45 and 80 years, diagnosed with ultrasound endometrial abnormalities and scheduled to have surgery were enrolled on a prospective study at Department of Gynaecologic Oncology of Campus Bio-Medico of Rome. Preoperative clinical, ultrasound and laboratory features were taken into account. Logistic regression algorithm was utilized to categorize patients into low and high risk groups for EC.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. aged between 45 and 80 years;\n2. Eastern Cooperative Oncology Group performance status 0-2 according to World Health Organization (WHO) criteria;\n3. informed consent obtained from the patients.\n\nExclusion Criteria:\n\n1. abnormal cardiac, haematological, renal, respiratory and/or hepatic functions;\n2. presence of a previous malignancy;\n3. presence of concomitant adnexal masses.'}, 'identificationModule': {'nctId': 'NCT01830192', 'acronym': 'REM', 'briefTitle': 'REM (Risk Of Endometrial Malignancy)', 'nctIdAliases': ['NCT01830179'], 'organization': {'class': 'OTHER', 'fullName': 'Campus Bio-Medico University'}, 'officialTitle': 'REM (Risk Of Endometrial Malignancy): A Proposal for a New Scoring System to Evaluate Risk of Endometrial Malignancy', 'orgStudyIdInfo': {'id': '47/09 RA CBM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Training set', 'description': 'We evaluate the clinical, ultrasound and laboratory features to predict endometrial cancer disease preoperative', 'interventionNames': ['Other: Training set']}, {'type': 'OTHER', 'label': 'VERIFICATION SET', 'description': 'We evaluate the clinical, ultrasound and laboratory features to predict endometrial cancer disease preoperative', 'interventionNames': ['Other: VERIFICATION SET']}], 'interventions': [{'name': 'Training set', 'type': 'OTHER', 'description': 'We evaluate the clinical, ultrasound and laboratory features to predict endometrial cancer disease preoperative', 'armGroupLabels': ['Training set']}, {'name': 'VERIFICATION SET', 'type': 'OTHER', 'description': 'We evaluate the clinical, ultrasound and laboratory features to predict endometrial cancer disease preoperative', 'armGroupLabels': ['VERIFICATION SET']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00128', 'city': 'Rome', 'country': 'Italy', 'facility': 'campus bio-medico of Rome', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': 'Roberto Angioli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Campus Biomedico University of Rome'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Campus Bio-Medico University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Roberto Angioli', 'investigatorAffiliation': 'Campus Bio-Medico University'}}}}