Endometrial Changes in Breast Cancer Women.
January 29, 2023 updated by: Benito Chiofalo, Regina Elena Cancer Institute
Endometrial Changes in Breast Cancer Women: a Prospective Multicentric Trial.
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.
Study Overview
Status
Active, not recruiting
Intervention / Treatment
Detailed Description
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.
Study Type
Observational
Enrollment (Anticipated)
829
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Lazio
-
Rome, Lazio, Italy, 00144
- IRCCS "Regina Elena" National Cancer Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Breast cancer patients, divided in three groups: tamoxifen users, aromatase inhibitors users and no therapies.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
TAM
Patients with previous breast cancer with hormonal receptor expression that are treated with tamoxifen.
|
Patients with suspected endometrial pathology, will undergo hysteroscopy with endometrial biopsy or endometrial lesion excision.
Other Names:
|
|
Ais
Patients with previous breast cancer with hormonal receptor expression that are treated with Ais.
|
Patients with suspected endometrial pathology, will undergo hysteroscopy with endometrial biopsy or endometrial lesion excision.
Other Names:
|
|
No Therapy
Patients with previous breast cancer that are not treated with none hormonal therapies.
|
Patients with suspected endometrial pathology, will undergo hysteroscopy with endometrial biopsy or endometrial lesion excision.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of endometrial cancer
Time Frame: One year
|
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
Time Frame: One year
|
Identification of ultrasonographic soft markers of endometrial pathology
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 26, 2023
Primary Completion (ANTICIPATED)
September 26, 2023
Study Completion (ANTICIPATED)
January 26, 2024
Study Registration Dates
First Submitted
January 29, 2023
First Submitted That Met QC Criteria
January 29, 2023
First Posted (ACTUAL)
February 8, 2023
Study Record Updates
Last Update Posted (ACTUAL)
February 8, 2023
Last Update Submitted That Met QC Criteria
January 29, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Regina Elena
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.