Endometrial Changes in Breast Cancer Women.

NCT05717634 | Unknown

• 1 other identifier: Regina Elena
• Study Type: observational
• Target: 829
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrial Cancer; Endometrial Hyperplasia With Atypia; Breast Cancer; TAM

Outcome Measures

Primary Outcomes (1)

• Incidence of endometrial cancer

  Evaluation of the incidence of endometrial cancer and atypical hyperplasya

  One year

Secondary Outcomes (1)

• Ultrasonographic soft markers of endometrial pathology

  One year

Study Arms (3)

TAM

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

Diagnostic Test: Hysteroscopy

Ais

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

Diagnostic Test: Hysteroscopy

No Therapy

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

Diagnostic Test: Hysteroscopy

Interventions

Hysteroscopy DIAGNOSTIC_TEST

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

Also known as: Endometrial biopsy

Ais; No Therapy; TAM

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Personal history of breast cancer

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

IRCCS "Regina Elena" National Cancer Institute

Rome, Lazio, 00144, Italy

Location

MeSH Terms

Conditions

Endometrial Neoplasms; Endometrial Hyperplasia; Breast Neoplasms

Interventions

Hysteroscopy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 29, 2023
• First Posted: February 8, 2023
• Study Start: January 26, 2023
• Primary Completion: September 26, 2023
• Study Completion: January 26, 2024
• Last Updated: February 8, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)