Endometrial Malignancy in Breast Cancer Patients With or Without AUB

Endometrial Neoplasms Clinical Trial

— TamAUB  

Official title:

Ultrasonographic, Hysteroscopic, Histopathologic Findings and Risk of Endometrial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05977829
• Other study ID #: 691
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: July 30, 2022

Study information

• Verified date: December 2023
• Source: University of Campania "Luigi Vanvitelli"
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 283
• Est. completion date: July 30, 2022
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 43 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Neoplasms

Intervention

Diagnostic Test:
• Ultrasound
Transvaginal ultrasound to carry out uterine surveillance
• Hysteroscopy
Outpatient hysteroscopy to carry out uterine surveillance

Locations

Country	Name	City	State
Italy	University of Cagliari	Cagliari

Sponsors (1)

Lead Sponsor	Collaborator
University of Campania "Luigi Vanvitelli"

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endometrial cancer rate		1 month after admission
Primary	Endometrial hyperplasia rate		1 month after admission