Endometrial Changes in Breast Cancer Women.

NCT ID: NCT05717634

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

829 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-26

Study Completion Date

2024-01-26

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Endometrial Cancer Endometrial Hyperplasia With Atypia Breast Cancer TAM

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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TAM

Patients with previous breast cancer with hormonal receptor expression that are treated with tamoxifen.

Hysteroscopy

Intervention Type DIAGNOSTIC_TEST

Patients with suspected endometrial pathology, will undergo hysteroscopy with endometrial biopsy or endometrial lesion excision.

Ais

Patients with previous breast cancer with hormonal receptor expression that are treated with Ais.

Hysteroscopy

Intervention Type DIAGNOSTIC_TEST

Patients with suspected endometrial pathology, will undergo hysteroscopy with endometrial biopsy or endometrial lesion excision.

No Therapy

Patients with previous breast cancer that are not treated with none hormonal therapies.

Hysteroscopy

Intervention Type DIAGNOSTIC_TEST

Patients with suspected endometrial pathology, will undergo hysteroscopy with endometrial biopsy or endometrial lesion excision.

Interventions

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Hysteroscopy

Patients with suspected endometrial pathology, will undergo hysteroscopy with endometrial biopsy or endometrial lesion excision.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Endometrial biopsy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Palermo

OTHER

Sponsor Role collaborator

University of Padova

OTHER

Sponsor Role collaborator

Universita di Verona

OTHER

Sponsor Role collaborator

Federico II University

OTHER

Sponsor Role collaborator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role collaborator

University of Messina

OTHER

Sponsor Role collaborator

IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

OTHER

Sponsor Role collaborator

Regina Elena Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Benito Chiofalo

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IRCCS "Regina Elena" National Cancer Institute

Rome, Lazio, Italy

Site Status

Countries

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Italy

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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Regina Elena

Identifier Type: -

Identifier Source: org_study_id

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