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Endometrial Changes in Breast Cancer Women.

Sponsor
Regina Elena Cancer Institute (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05717634
Collaborator
University of Palermo (Other), University of Padova (Other), Universita di Verona (Other), Federico II University (Other), Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other), University of Messina (Other), IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy (Other)
829
Enrollment
1
Location
12
Anticipated Duration (Months)
69.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Hysteroscopy

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 Design

Study Type:
Observational
Anticipated Enrollment :
829 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Endometrial Changes in Breast Cancer Women: a Prospective Multicentric Trial.
Actual Study Start Date :
Jan 26, 2023
Anticipated Primary Completion Date :
Sep 26, 2023
Anticipated Study Completion Date :
Jan 26, 2024

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of endometrial cancer [One year]

      Evaluation of the incidence of endometrial cancer and atypical hyperplasya

    Secondary Outcome Measures

    1. Ultrasonographic soft markers of endometrial pathology [One year]

      Identification of ultrasonographic soft markers of endometrial pathology

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 IRCCS "Regina Elena" National Cancer Institute Rome Lazio Italy 00144

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Benito Chiofalo, MD, PhD, Regina Elena Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT05717634
    Other Study ID Numbers:
    • Regina Elena
    First Posted:
    Feb 8, 2023
    Last Update Posted:
    Feb 8, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms
    Endometrial Neoplasms
    Endometrial Hyperplasia
    Hyperplasia

    Study Results

    No Results Posted as of Feb 8, 2023