Endometrial Malignancy in Breast Cancer Patients With or Without AUB (TamAUB)

December 22, 2023 updated by: Gaetano Riemma, University of Campania "Luigi Vanvitelli"

Ultrasonographic, Hysteroscopic, Histopathologic Findings and Risk of Endometrial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

283

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Cagliari, Italy
        • University of Cagliari

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Women undergoing gynecological examinations for endometrial surveillance related to selective estrogen receptor modulators, aromatase inhibitors or other hormone therapy for breast cancer

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Endometrial cancer rate
Time Frame: 1 month after admission
1 month after admission
Endometrial hyperplasia rate
Time Frame: 1 month after admission
1 month after admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

June 1, 2021

Study Completion (Actual)

July 30, 2022

Study Registration Dates

First Submitted

July 28, 2023

First Submitted That Met QC Criteria

August 3, 2023

First Posted (Actual)

August 4, 2023

Study Record Updates

Last Update Posted (Actual)

December 26, 2023

Last Update Submitted That Met QC Criteria

December 22, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 691

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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