Endometrial Malignancy in Breast Cancer Patients With or Without AUB

NCT ID: NCT05977829

Last Updated: 2023-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

283 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2022-07-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Endometrial Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Breast cancer patients with abnormal uterine bleeding

* Transvaginal ultrasonography
* Outpatient Hysteroscopy

Ultrasound

Intervention Type DIAGNOSTIC_TEST

Transvaginal ultrasound to carry out uterine surveillance

Hysteroscopy

Intervention Type DIAGNOSTIC_TEST

Outpatient hysteroscopy to carry out uterine surveillance

Breast cancer patients without abnormal uterine bleeding

* Transvaginal ultrasonography
* Outpatient Hysteroscopy

Ultrasound

Intervention Type DIAGNOSTIC_TEST

Transvaginal ultrasound to carry out uterine surveillance

Hysteroscopy

Intervention Type DIAGNOSTIC_TEST

Outpatient hysteroscopy to carry out uterine surveillance

Interventions

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Ultrasound

Transvaginal ultrasound to carry out uterine surveillance

Intervention Type DIAGNOSTIC_TEST

Hysteroscopy

Outpatient hysteroscopy to carry out uterine surveillance

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* In case of AUB: ultrasonographic endometrial thickness \>5 mm at transvaginal ultrasound
* In case of non-AUB group ultrasonographic suspicion of endometrial or myometrial abnormalities

Exclusion Criteria

* severe comorbidities (cardiovascular, metabolic, endocrine, and immunological disorders)
* receiving any other form of pharmacologic therapy
Minimum Eligible Age

43 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Campania Luigi Vanvitelli

OTHER

Sponsor Role lead

Responsible Party

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Gaetano Riemma

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gaetano Riemma, MD

Role: PRINCIPAL_INVESTIGATOR

University of Campania Luigi Vanvitelli

Pasquale De Franciscis, MD PhD

Role: STUDY_CHAIR

University of Campania Luigi Vanvitelli

Locations

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University of Cagliari

Cagliari, , Italy

Site Status

Countries

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Italy

Other Identifiers

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691

Identifier Type: -

Identifier Source: org_study_id