Endometrial Changes in Breast Cancer Women.

Study Overview
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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.

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

Conditions
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TAM, Endometrial Cancer, Endometrial Hyperplasia With Atypia, Breast Cancer

Intervention / Treatment
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* Diagnostic Test: Hysteroscopy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TAM<br>Patients with previous breast cancer with hormonal receptor expression that are treated with tamoxifen. | Diagnostic Test: Hysteroscopy<br>* Patients with suspected endometrial pathology, will undergo hysteroscopy with endometrial biopsy or endometrial lesion excision.<br>* Other names: Endometrial biopsy;|
| Ais<br>Patients with previous breast cancer with hormonal receptor expression that are treated with Ais. | Diagnostic Test: Hysteroscopy<br>* Patients with suspected endometrial pathology, will undergo hysteroscopy with endometrial biopsy or endometrial lesion excision.<br>* Other names: Endometrial biopsy;|
| No Therapy<br>Patients with previous breast cancer that are not treated with none hormonal therapies. | Diagnostic Test: Hysteroscopy<br>* Patients with suspected endometrial pathology, will undergo hysteroscopy with endometrial biopsy or endometrial lesion excision.<br>* Other names: Endometrial biopsy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of endometrial cancer | Evaluation of the incidence of endometrial cancer and atypical hyperplasya | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasonographic soft markers of endometrial pathology | Identification of ultrasonographic soft markers of endometrial pathology | One year |