Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-24 @ 5:49 PM
Study NCT ID:
NCT06825468
Status:
COMPLETED
Last Update Posted:
2025-02-13
First Post:
2024-12-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Role of Hysterectomy in the Treatment of Borderline Ovarian Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 168}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-11', 'studyFirstSubmitDate': '2024-12-30', 'studyFirstSubmitQcDate': '2025-02-11', 'lastUpdatePostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact of uterine preservation on the rate of BOT recurrence', 'timeFrame': 'After surgery during follow up (up to 20 years)', 'description': 'Impact of uterine preservation on the rate of borderline ovarian tumors (BOT) recurrence and thus its usefulness or otherwise in clinical care practice; therefore, the overall recurrence rate (which includes BOT, invasive BOT implants, and carcinoma) in patients treated with (group 1) and without (group 2) hysterectomy will be determined'}], 'secondaryOutcomes': [{'measure': 'The rate of recurrence of BOT and of invasive implants', 'timeFrame': 'After surgery during follow up (up to 20 years)', 'description': 'Improved care practice by determining in patients with BOT undergoing (group 1) or not undergoing (group 2) hysterectomy the rate of recurrence of BOT and of invasive implants'}, {'measure': 'The rate of carcinoma recurrence', 'timeFrame': 'After surgery during follow up (up to 20 years)', 'description': 'Improved care practice by determining in patients with BOT undergoing (group 1) or not undergoing (group 2) hysterectomy the rate of carcinoma recurrence'}, {'measure': "the overall survival (OS) defined as the time from surgery to the patient's death from any cause", 'timeFrame': 'After surgery during follow up (up to 20 years)', 'description': "Improved care practice by determining in patients with BOT undergoing (group 1) or not undergoing (group 2) hysterectomy the overall survival (OS) defined as the time from surgery to the patient's death from any cause"}, {'measure': 'disease-free survival (DFS) defined as time from surgery to recurrence', 'timeFrame': 'After surgery during follow up', 'description': 'Improved care practice by determining in patients with BOT undergoing (group 1) or not undergoing (group 2) hysterectomy disease-free survival (DFS) defined as time from surgery to recurrence'}, {'measure': 'disease-specific survival (DSS) defined as the time from first surgery for BOT to death from disease', 'timeFrame': 'After surgery during follow up (up to 20 years)', 'description': 'Improved care practice by determining in patients with BOT undergoing (group 1) or not undergoing (group 2) hysterectomy disease-specific survival (DSS) defined as the time from first surgery for BOT to death from disease'}, {'measure': 'the rate of postoperative complications', 'timeFrame': 'After surgery during follow up (up to 20 years)', 'description': 'Improved care practice by determining in patients with BOT undergoing (group 1) or not undergoing (group 2) hysterectomy the rate of postoperative complications'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Borderline ovarian tumours', 'gynaecology', 'perimenopause', 'postmenopause'], 'conditions': ['Hysterectomy']}, 'descriptionModule': {'briefSummary': 'Borderline ovarian tumors (BOT), are rare epithelial ovarian tumors characterized by the presence of frankly malignant cytologic features in the absence of stromal invasion.\n\nSurgical treatment of perimenopausal and postmenopausal BOT requires bilateral adnexectomy. Although some studies have reported an increased recurrence rate in the group of patients treated with uterine preservation, these data are severely limited by the small sample of patients and the presence of confounding factors in the analysis of oncologic outcomes.\n\nDetermining the impact of hysterectomy on the survival outcomes of perimenopausal and postmenopausal patients diagnosed with early FIGO stage BOT is necessary to avoid overtreatment, hysterectomy being associated with a low but not negligible rate of morbidity and mortality.', 'detailedDescription': 'Borderline ovarian tumors (BOTs), are rare epithelial ovarian tumors characterized by the presence of frankly malignant cytologic features in the absence of stromal invasion. Serous BOTs, which account for 67% of all BOTs, are limited to one ovary in 75% of cases and are frequently accompanied by predominantly noninvasive peritoneal implants. In 30% of cases, BOTs are mucinous, unilateral, and characterized by a low rate of extra-ovarian spread and invasive implants. Patients with BOT are diagnosed at FIGO stage I in 78.9% of cases, are usually young, and have a favorable prognosis with 5-year survival affecting more than 80% of patients.\n\nSurgical treatment of perimenopausal and postmenopausal BOT requires bilateral annissiectomy. Otherwise, the role of hysterectomy in perimenopausal and postmenopausal women with early-stage BOT remains unclear. Although some studies have reported an increased recurrence rate in the group of patients treated with uterine preservation, these data are severely limited by the small sample of patients and the presence of confounding factors in the analysis of oncologic outcomes.\n\nDetermining the impact of hysterectomy on the survival outcomes of perimenopausal and postmenopausal patients diagnosed with early FIGO stage BOT is necessary to avoid overtreatment, hysterectomy being associated with a low but not negligible rate of morbidity and mortality.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with BOT diagnosis will be included in the study for analysis:\n\n* BSO and hysterectomy (group 1)\n* BSO without hysterectomy (group 2)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women in menopause clinically defined as absence of menstrual cycle for 12 months\n* Primary diagnosis of BOT confirmed by pathological examination\n* Surgical treatment of BOT by BSO with (group 1) and without (group 2) hysterectomy\n* Informed consent acquisition\n\nExclusion Criteria:\n\n* Occurrence of BOT at index intervention\n* Stage IV\n* Metastatic disease\n* Patients with previous hysterectomy\n* Cancer synchronous of the endometrium\n* Patients who have not had follow-up before 5 years (excluding those who have not reached the 5 year follow-up for the following events: death from any cause, death from BOT, recurrence of BOT)'}, 'identificationModule': {'nctId': 'NCT06825468', 'briefTitle': 'Role of Hysterectomy in the Treatment of Borderline Ovarian Tumors', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}, 'officialTitle': 'Role Of Hysterectomy In The Treatment Of Borderline Ovarian Tumors', 'orgStudyIdInfo': {'id': 'HYSTEROBOT'}}, 'contactsLocationsModule': {'locations': [{'zip': '40138', 'city': 'Bologna', 'country': 'Italy', 'facility': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '00136', 'city': 'Roma', 'country': 'Italy', 'facility': 'Fondazione Policlinico Universitario A. Gemelli, IRCCS', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '33100', 'city': 'Udine', 'country': 'Italy', 'facility': 'Ospedale universitario, Azienda Sanitaria Universitaria Friuli Centrale', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}], 'overallOfficials': [{'name': 'Diego Raimondo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}