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| Name | Class |
|---|---|
| University of Palermo | OTHER |
| University of Padova | OTHER |
| Universita di Verona | OTHER |
| Federico II University |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAM | Patients with previous breast cancer with hormonal receptor expression that are treated with tamoxifen. |
| |
| Ais | Patients with previous breast cancer with hormonal receptor expression that are treated with Ais. |
| |
| No Therapy | Patients with previous breast cancer that are not treated with none hormonal therapies. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hysteroscopy | Diagnostic Test | Patients with suspected endometrial pathology, will undergo hysteroscopy with endometrial biopsy or endometrial lesion excision. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of endometrial cancer | Evaluation of the incidence of endometrial cancer and atypical hyperplasya | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Ultrasonographic soft markers of endometrial pathology | Identification of ultrasonographic soft markers of endometrial pathology | One year |
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Inclusion Criteria:
Exclusion Criteria:
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Breast cancer patients, divided in three groups: tamoxifen users, aromatase inhibitors users and no therapies.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS "Regina Elena" National Cancer Institute | Rome | Lazio | 00144 | Italy |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Dec 28, 2022 | Jan 29, 2023 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| D004714 | Endometrial Hyperplasia |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D015907 | Hysteroscopy |
| ID | Term |
|---|---|
| D003944 | Diagnostic Techniques, Obstetrical and Gynecological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
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| OTHER |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | OTHER |
| University of Messina | OTHER |
| IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy | OTHER |
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|
| 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 |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| 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 |