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NCT05717634 Clinical Trial

Endometrial Changes in Breast Cancer Women.

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05717634
Other study ID # Regina Elena
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 26, 2023
Est. completion date January 26, 2024

Study information
Verified date January 2023
Source Regina Elena Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 829
Est. completion date January 26, 2024
Est. primary completion date September 26, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Hysteroscopy
Patients with suspected endometrial pathology, will undergo hysteroscopy with endometrial biopsy or endometrial lesion excision.

Locations
Country Name City State
Italy IRCCS "Regina Elena" National Cancer Institute Rome Lazio

Sponsors (8)
Lead Sponsor Collaborator
Regina Elena Cancer Institute Federico II University, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy, Universita di Verona, University of Messina, University of Padova, University of Palermo

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of endometrial cancer Evaluation of the incidence of endometrial cancer and atypical hyperplasya One year
Secondary Ultrasonographic soft markers of endometrial pathology Identification of ultrasonographic soft markers of endometrial pathology One year
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