Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2026-03-09 @ 8:18 AM
Study NCT ID:
NCT05793333
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2023-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictors of Node Positivity in Endometrial Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016889', 'term': 'Endometrial 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': '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': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-15', 'studyFirstSubmitDate': '2023-03-04', 'studyFirstSubmitQcDate': '2023-03-29', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'positive nodes', 'timeFrame': '12 months', 'description': 'positive nodes detected by sentinel node mappinig'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sentinel node', 'endometrial cancer'], 'conditions': ['Endometrial Cancer']}, 'referencesModule': {'references': [{'pmid': '38658017', 'type': 'DERIVED', 'citation': 'Bogani G, Lalli L, Casarin J, Ghezzi F, Chiappa V, Fanfani F, Scambia G, Raspagliesi F. Predicting the Risk of nOdal disease with histological and Molecular features in Endometrial cancer: the prospective PROME trial. Int J Gynecol Cancer. 2024 Sep 2;34(9):1366-1372. doi: 10.1136/ijgc-2024-005416.'}]}, 'descriptionModule': {'briefSummary': 'To investigate the role of histological and moleculr profile of endometrial cancer patietns in predicting the risk of nodal metastases in endometrila cancer patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patietns were submitted to standard treatment modality for managing endometrial cancer. They will receive hsyterectomy (with or without bilateral salpingo-oophorectomy) plus sentinel ndoe mapping.\n\nAfter the procedures data regarding hystologcial charactersitcs of the tumor and molecular features will be analyzed (as routine cliical practice).\n\nWe will correlate those data with findings achieved by sentinel nodes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent\n* Histologically confirmed endometrila cancer\n* Data on molecular genomic profiling (POLE mutated, p53 abnormalities, MMRd/MSI-H, and NSMP)\n* Data on histological characteristics of the ttumor\n* Execution of sentinel node mapping\n* Data on sentinel node status (negative vs. positive)\n\nExclusion Criteria:\n\n* Stage IVB endoemtrial cancer\n* consent withdraw'}, 'identificationModule': {'nctId': 'NCT05793333', 'briefTitle': 'Predictors of Node Positivity in Endometrial Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milano'}, 'officialTitle': 'Histological and Molecular Characteristics Predict the Risk of Nodal Involvement in Endometrial Cancer: a Prospective Study', 'orgStudyIdInfo': {'id': '142020'}}, 'contactsLocationsModule': {'locations': [{'zip': '20148', 'city': 'Milan', 'state': 'Lombardy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giorgio Bogani', 'role': 'CONTACT', 'email': 'giorgiobogani@yahoo.it', 'phone': '+393803933116'}, {'name': 'Valentina Chiappa, MD', 'role': 'CONTACT', 'email': 'valentina.chiappa@istitutotumori.mi.it', 'phone': '+0223901'}], 'facility': 'Fondazione IRCCS Istituto Nazionale dei Tumori', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Grazia M Casadei, ph.d.', 'role': 'CONTACT', 'email': 'grazia.casadei@istitutotumori.mi.it', 'phone': '917-275-6975'}], 'overallOfficials': [{'name': 'Giorgio Bogani, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milano'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milano', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Valentina Chiappa', 'investigatorAffiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milano'}}}}