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In order to assess the hysteroscopic, histopathologic, and ultrasonographic aspects of uterine monitoring in postmenopausal breast cancer patients with or without abnormal uterine bleeding (AUB), as well as to calculate the risk of endometrial cancer in women with or without AUB.
20-25% of postmenopausal women undergoing tamoxifen (TAM) therapy develop polyps, according to recent studies. Many large (>2 cm) and molecularly changed uterine polyps are usually seen in these women. Furthermore, a number of studies have demonstrated that TAM therapy raises the risk of endometrial cancer in both premenopausal and postmenopausal women. Studies suggest that women who use TAM may also have an increase in the prevalence of uterine sarcomas. In addition, the duration of TAM administration appears to increase the risk of endometrial cancer and uterine sarcoma.
This multicentric cohort study will compare the ultrasonographic, hysteroscopic, and histopathologic findings in postmenopausal women treated for breast cancer with or without AUB in order to increase the robustness of a still ambiguous literature on the subject. It will estimate the risk of endometrial cancer in women with AUB according to various covariates related to the breast neoplasm or the ultrasonographic and hysteroscopic features.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast cancer patients with abnormal uterine bleeding |
|
| |
| Breast cancer patients without abnormal uterine bleeding |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound | Diagnostic Test | Transvaginal ultrasound to carry out uterine surveillance |
|
| Measure | Description | Time Frame |
|---|---|---|
| Endometrial cancer rate | 1 month after admission | |
| Endometrial hyperplasia rate | 1 month after admission |
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Inclusion Criteria:
Exclusion Criteria:
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Women undergoing gynecological examinations for endometrial surveillance related to selective estrogen receptor modulators, aromatase inhibitors or other hormone therapy for breast cancer
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| Name | Affiliation | Role |
|---|---|---|
| Gaetano Riemma, MD | University of Campania Luigi Vanvitelli | Principal Investigator |
| Pasquale De Franciscis, MD PhD | University of Campania Luigi Vanvitelli | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cagliari | Cagliari | Italy |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| D015907 | Hysteroscopy |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003944 | Diagnostic Techniques, Obstetrical and Gynecological |
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Endometrial biopsy for histopathological analysis.
| Hysteroscopy | Diagnostic Test | Outpatient hysteroscopy to carry out uterine surveillance |
|
| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013513 | Obstetric Surgical Procedures |
| D013509 | Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |