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OpenTrials
Completed

NCT Number: NCT05977829

Endometrial Malignancy in Breast Cancer Patients With or Without AUB

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.

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Key information

Conditions

Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

43 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Cagliari

Cagliari, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound

Diagnostic Test

Transvaginal ultrasound to carry out uterine surveillance

Hysteroscopy

Diagnostic Test

Outpatient hysteroscopy to carry out uterine surveillance

Primary outcomes

  1. Endometrial cancer rate

    Time frame: 1 month after admission

  2. Endometrial hyperplasia rate

    Time frame: 1 month after admission

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Registry information

Official study title

Ultrasonographic, Hysteroscopic, Histopathologic Findings and Risk of Endometrial

Acronym: TamAUB

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Aug 4, 2023
Registry last updated
Dec 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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