Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-30 @ 3:29 PM
Study NCT ID:
NCT05717634
Status:
UNKNOWN
Last Update Posted:
2023-02-08
First Post:
2023-01-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endometrial Changes in Breast Cancer Women.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D004714', 'term': 'Endometrial Hyperplasia'}, {'id': 'D001943', 'term': 'Breast 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'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015907', 'term': 'Hysteroscopy'}], 'ancestors': [{'id': 'D003944', 'term': 'Diagnostic Techniques, Obstetrical and Gynecological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013513', 'term': 'Obstetric Surgical Procedures'}, {'id': 'D013509', 'term': 'Gynecologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-12-28', 'size': 1113454, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2023-01-29T15:57', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 829}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2024-01-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-29', 'studyFirstSubmitDate': '2023-01-29', 'studyFirstSubmitQcDate': '2023-01-29', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of endometrial cancer', 'timeFrame': 'One year', 'description': 'Evaluation of the incidence of endometrial cancer and atypical hyperplasya'}], 'secondaryOutcomes': [{'measure': 'Ultrasonographic soft markers of endometrial pathology', 'timeFrame': 'One year', 'description': 'Identification of ultrasonographic soft markers of endometrial pathology'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endometrial Cancer', 'Endometrial Hyperplasia With Atypia', 'Breast Cancer', 'TAM']}, 'descriptionModule': {'briefSummary': 'This is a prospective observational multicentric study. The aim is to evaluate the incidence of endometrial cancer and endometrial atypical hyperplasia in patients with previous breast cancer, treated with different adjuvant therapies. The second aim is to identify ultrasonographic soft markers related with endometrial cancer or atipycal hyperplasia.', 'detailedDescription': 'This is a prospective observational multicentric study. Patient with a history of breast cancer treated with adjuvant hormonal therapies or with no therapies, will be enrolled and followed once a year with physical exam and endovaginal ultrasound. Patients with suspected endometrial pathology will undergo hysteroscopy with endometrial biopsy or endometrial lesion resection.\n\nThe aim is to evaluate the incidence of endometrial cancer and endometrial atypical hyperplasia in patients with previous breast cancer, treated with different adjuvant therapies. The second aim is to identify ultrasonographic soft markers related with endometrial cancer or atipycal hyperplasia.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Breast cancer patients, divided in three groups: tamoxifen users, aromatase inhibitors users and no therapies.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Personal history of breast cancer\n\nExclusion Criteria:\n\n* Personal history of other hormonal sensitive cancers\n* Assumption of hormones in the previous 5 years\n* Previous medical assisted reproduction technique\n* Lynch syndrome or BRCA 1/2 mutations'}, 'identificationModule': {'nctId': 'NCT05717634', 'briefTitle': 'Endometrial Changes in Breast Cancer Women.', 'organization': {'class': 'OTHER', 'fullName': 'Regina Elena Cancer Institute'}, 'officialTitle': 'Endometrial Changes in Breast Cancer Women: a Prospective Multicentric Trial.', 'orgStudyIdInfo': {'id': 'Regina Elena'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TAM', 'description': 'Patients with previous breast cancer with hormonal receptor expression that are treated with tamoxifen.', 'interventionNames': ['Diagnostic Test: Hysteroscopy']}, {'label': 'Ais', 'description': 'Patients with previous breast cancer with hormonal receptor expression that are treated with Ais.', 'interventionNames': ['Diagnostic Test: Hysteroscopy']}, {'label': 'No Therapy', 'description': 'Patients with previous breast cancer that are not treated with none hormonal therapies.', 'interventionNames': ['Diagnostic Test: Hysteroscopy']}], 'interventions': [{'name': 'Hysteroscopy', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Endometrial biopsy'], 'description': 'Patients with suspected endometrial pathology, will undergo hysteroscopy with endometrial biopsy or endometrial lesion excision.', 'armGroupLabels': ['Ais', 'No Therapy', 'TAM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00144', 'city': 'Rome', 'state': 'Lazio', 'country': 'Italy', 'facility': 'IRCCS "Regina Elena" National Cancer Institute', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regina Elena Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Palermo', 'class': 'OTHER'}, {'name': 'University of Padova', 'class': 'OTHER'}, {'name': 'Universita di Verona', 'class': 'OTHER'}, {'name': 'Federico II University', 'class': 'OTHER'}, {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, {'name': 'University of Messina', 'class': 'OTHER'}, {'name': 'IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Benito Chiofalo', 'investigatorAffiliation': 'Regina Elena Cancer Institute'}}}}