Endometrial Malignancy in Breast Cancer Patients With or Without AUB

Completed

• Conditions: Endometrial Neoplasms
• Interventions: Diagnostic Test: Ultrasound; Diagnostic Test: Hysteroscopy

• Registration Number: NCT05977829
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

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.

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2021-06-01
• Study Completion: 2022-07-30
• Study First Submitted: 2023-07-28
• Study First Submitted QC: 2023-08-03
• Study First Posted: 2023-08-04
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-22
• Last Update Posted: 2023-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 283

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Breast cancer patients with abnormal uterine bleeding	Ultrasound	* Transvaginal ultrasonography * Outpatient Hysteroscopy
Breast cancer patients without abnormal uterine bleeding	Ultrasound	* Transvaginal ultrasonography * Outpatient Hysteroscopy
Breast cancer patients with abnormal uterine bleeding	Hysteroscopy	* Transvaginal ultrasonography * Outpatient Hysteroscopy
Breast cancer patients without abnormal uterine bleeding	Hysteroscopy	* Transvaginal ultrasonography * Outpatient Hysteroscopy

Primary Outcome Measures

Name	Time	Method
Endometrial cancer rate	1 month after admission
Endometrial hyperplasia rate	1 month after admission

Trial Locations

Locations (1)

University of Cagliari; 🇮🇹 Cagliari, Italy