Endometrial Malignancy in Breast Cancer Patients With or Without AUB
NCT ID: NCT05977829
Last Updated: 2023-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
283 participants
OBSERVATIONAL
2020-01-01
2022-07-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Breast cancer patients with abnormal uterine bleeding
* Transvaginal ultrasonography
* Outpatient Hysteroscopy
Ultrasound
Transvaginal ultrasound to carry out uterine surveillance
Hysteroscopy
Outpatient hysteroscopy to carry out uterine surveillance
Breast cancer patients without abnormal uterine bleeding
* Transvaginal ultrasonography
* Outpatient Hysteroscopy
Ultrasound
Transvaginal ultrasound to carry out uterine surveillance
Hysteroscopy
Outpatient hysteroscopy to carry out uterine surveillance
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ultrasound
Transvaginal ultrasound to carry out uterine surveillance
Hysteroscopy
Outpatient hysteroscopy to carry out uterine surveillance
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* In case of non-AUB group ultrasonographic suspicion of endometrial or myometrial abnormalities
Exclusion Criteria
* receiving any other form of pharmacologic therapy
43 Years
70 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Campania Luigi Vanvitelli
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Gaetano Riemma
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
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
Explore where the study is taking place and check the recruitment status at each participating site.
University of Cagliari
Cagliari, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
691
Identifier Type: -
Identifier Source: org_study_id