NCT05717634

Endometrial Changes in Breast Cancer Women.

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 829 (estimated)
• Sponsor: Regina Elena Cancer Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Endometrial Cancer
• Endometrial Hyperplasia With Atypia
• Breast Cancer
• TAM

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Hysteroscopy	Patients with suspected endometrial pathology, will undergo hysteroscopy with endometrial biopsy or endometrial lesion excision.

Timeline

• Start date: 2023-01-26
• Primary completion: 2023-09-26
• Completion: 2024-01-26
• First posted: 2023-02-08
• Last updated: 2023-02-08

Locations

1 site across 1 country: Italy