TamAUB: Endometrial Malignancy in Breast Cancer Patients With or Without AUB
Study Details
Study Description
Brief Summary
In order to assess the hysteroscopic, histopathologic, and ultrasonographic aspects of uterine monitoring in postmenopausal breast cancer patients with or without abnormal uterine bleeding (AUB), as well as to calculate the risk of endometrial cancer in women with or without AUB.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
20-25% of postmenopausal women undergoing tamoxifen (TAM) therapy develop polyps, according to recent studies. Many large (>2 cm) and molecularly changed uterine polyps are usually seen in these women. Furthermore, a number of studies have demonstrated that TAM therapy raises the risk of endometrial cancer in both premenopausal and postmenopausal women. Studies suggest that women who use TAM may also have an increase in the prevalence of uterine sarcomas. In addition, the duration of TAM administration appears to increase the risk of endometrial cancer and uterine sarcoma.
This multicentric cohort study will compare the ultrasonographic, hysteroscopic, and histopathologic findings in postmenopausal women treated for breast cancer with or without AUB in order to increase the robustness of a still ambiguous literature on the subject. It will estimate the risk of endometrial cancer in women with AUB according to various covariates related to the breast neoplasm or the ultrasonographic and hysteroscopic features.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Breast cancer patients with abnormal uterine bleeding Transvaginal ultrasonography Outpatient Hysteroscopy |
Diagnostic Test: Ultrasound
Transvaginal ultrasound to carry out uterine surveillance
Diagnostic Test: Hysteroscopy
Outpatient hysteroscopy to carry out uterine surveillance
|
| Breast cancer patients without abnormal uterine bleeding Transvaginal ultrasonography Outpatient Hysteroscopy |
Diagnostic Test: Ultrasound
Transvaginal ultrasound to carry out uterine surveillance
Diagnostic Test: Hysteroscopy
Outpatient hysteroscopy to carry out uterine surveillance
|
Outcome Measures
Primary Outcome Measures
- Endometrial cancer rate [1 month after admission]
- Endometrial hyperplasia rate [1 month after admission]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
In case of AUB: ultrasonographic endometrial thickness >5 mm at transvaginal ultrasound
-
In case of non-AUB group ultrasonographic suspicion of endometrial or myometrial abnormalities
Exclusion Criteria:
-
severe comorbidities (cardiovascular, metabolic, endocrine, and immunological disorders)
-
receiving any other form of pharmacologic therapy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Bologna Alma Mater Studiorum | Bologna | Italy | ||
| 2 | University of Cagliari | Cagliari | Italy | ||
| 3 | University of Genoa | Genova | Italy | ||
| 4 | University of Naples Federico II | Napoli | Italy |
Sponsors and Collaborators
- University of Campania "Luigi Vanvitelli"
Investigators
- Principal Investigator: Gaetano Riemma, MD, University of Campania "Luigi Vanvitelli"
- Study Chair: Pasquale De Franciscis, MD PhD, University of Campania "Luigi Vanvitelli"
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 691