Ultrasonographic, Hysteroscopic, Histopathologic Findings and Risk of Endometrial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Endometrial Neoplasms
- Sponsor
- University of Campania "Luigi Vanvitelli"
- Enrollment
- 283
- Locations
- 1
- Primary Endpoint
- Endometrial cancer rate
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
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.
Investigators
Gaetano Riemma
Principal Investigator
University of Campania "Luigi Vanvitelli"
Eligibility 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
Outcomes
Primary Outcomes
Endometrial cancer rate
Time Frame: 1 month after admission
Endometrial hyperplasia rate
Time Frame: 1 month after admission