Endometrial Changes in Breast Cancer Women.

January 29, 2023 updated by: Benito Chiofalo, Regina Elena Cancer Institute

Endometrial Changes in Breast Cancer Women: a Prospective Multicentric Trial.

This is a prospective observational multicentric study. The aim is to evaluate the incidence of endometrial cancer and endometrial atypical hyperplasia in patients with previous breast cancer, treated with different adjuvant therapies. The second aim is to identify ultrasonographic soft markers related with endometrial cancer or atipycal hyperplasia.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective observational multicentric study. Patient with a history of breast cancer treated with adjuvant hormonal therapies or with no therapies, will be enrolled and followed once a year with physical exam and endovaginal ultrasound. Patients with suspected endometrial pathology will undergo hysteroscopy with endometrial biopsy or endometrial lesion resection.

The aim is to evaluate the incidence of endometrial cancer and endometrial atypical hyperplasia in patients with previous breast cancer, treated with different adjuvant therapies. The second aim is to identify ultrasonographic soft markers related with endometrial cancer or atipycal hyperplasia.

Study Type

Observational

Enrollment (Anticipated)

829

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
    • Lazio
      • Rome, Lazio, Italy, 00144
        • IRCCS "Regina Elena" National Cancer Institute

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Breast cancer patients, divided in three groups: tamoxifen users, aromatase inhibitors users and no therapies.

Description

Inclusion Criteria:

  • Personal history of breast cancer

Exclusion Criteria:

  • Personal history of other hormonal sensitive cancers
  • Assumption of hormones in the previous 5 years
  • Previous medical assisted reproduction technique
  • Lynch syndrome or BRCA 1/2 mutations

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
TAM
Patients with previous breast cancer with hormonal receptor expression that are treated with tamoxifen.
Diagnostic test: Hysteroscopy
Patients with suspected endometrial pathology, will undergo hysteroscopy with endometrial biopsy or endometrial lesion excision.
Other Names:
  • Endometrial biopsy
Ais
Patients with previous breast cancer with hormonal receptor expression that are treated with Ais.
Diagnostic test: Hysteroscopy
Patients with suspected endometrial pathology, will undergo hysteroscopy with endometrial biopsy or endometrial lesion excision.
Other Names:
  • Endometrial biopsy
No Therapy
Patients with previous breast cancer that are not treated with none hormonal therapies.
Diagnostic test: Hysteroscopy
Patients with suspected endometrial pathology, will undergo hysteroscopy with endometrial biopsy or endometrial lesion excision.
Other Names:
  • Endometrial biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of endometrial cancer
Time Frame: One year
Evaluation of the incidence of endometrial cancer and atypical hyperplasya
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ultrasonographic soft markers of endometrial pathology
Time Frame: One year
Identification of ultrasonographic soft markers of endometrial pathology
One year

Collaborators and Investigators

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

Sponsor

Regina Elena Cancer Institute

Collaborators

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
University of Palermo
Federico II University
Universita di Verona
University of Padova
University of Messina
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

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 26, 2023

Primary Completion (ANTICIPATED)

September 26, 2023

Study Completion (ANTICIPATED)

January 26, 2024

Study Registration Dates

First Submitted

January 29, 2023

First Submitted That Met QC Criteria

January 29, 2023

First Posted (ACTUAL)

February 8, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

January 29, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Regina Elena

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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