Endometrial CancerNCT05717634
Endometrial Changes in Breast Cancer Women.
An observational study of Endometrial Cancer and Endometrial Hyperplasia With Atypia, run by Regina Elena Cancer Institute at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Cancer, Endometrial Hyperplasia With Atypia, Breast Cancer
- What is being tested?
- Hysteroscopy
- How many people
- 829 participants
- Where
- 1 siteItaly
- Study dates
- 26 Jan 2023to 26 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Breast cancer patients, divided in three groups: tamoxifen users, aromatase inhibitors users and no therapies.
Who may be able to join
- Personal history of breast cancer
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Hysteroscopy
- Medical subject headings
- Endometrial Neoplasms, Endometrial Hyperplasia, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HysteroscopyDiagnostic test
Also called Endometrial biopsy
Patients with suspected endometrial pathology, will undergo hysteroscopy with endometrial biopsy or endometrial lesion excision.
| Study group | Role | What they receive |
|---|---|---|
| TAM | Patients with previous breast cancer with hormonal receptor expression that are treated with tamoxifen. Receives: Diagnostic Test: Hysteroscopy | |
| Ais | Patients with previous breast cancer with hormonal receptor expression that are treated with Ais. Receives: Diagnostic Test: Hysteroscopy | |
| No Therapy | Patients with previous breast cancer that are not treated with none hormonal therapies. Receives: Diagnostic Test: Hysteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of endometrial cancer
Evaluation of the incidence of endometrial cancer and atypical hyperplasya
Measured: One year
Secondary outcomes (1)
Ultrasonographic soft markers of endometrial pathology
Identification of ultrasonographic soft markers of endometrial pathology
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start26 Jan 2023
- Primary completion26 Sep 2023 (estimated)
- Study completion26 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 829 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Palermo, University of Padova, Universita di Verona, Federico II University, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, University of Messina, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
- Responsible party
- Principal investigator, Benito Chiofalo, Regina Elena Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05717634
- Sponsor's protocol ID
- Regina Elena
- Status last verified
- Jan 2023
- First submitted
- 29 Jan 2023
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometrial Changes in Breast Cancer Women: a Prospective Multicentric Trial.
- ClinicalTrials.gov ID
- NCT05717634
- Acronym / sponsor ID
- Regina Elena
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 829 participants (estimated)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Collaborators
- University of Palermo, University of Padova, Universita di Verona, Federico II University, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, University of Messina, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
- Study start
- 26 Jan 2023 (actual)
- Primary completion
- 26 Sep 2023 (estimated)
- Study completion
- 26 Jan 2024 (estimated)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TAM | – | Diagnostic Test: HysteroscopyPatients with previous breast cancer with hormonal receptor expression that are treated with tamoxifen. |
| Ais | – | Diagnostic Test: HysteroscopyPatients with previous breast cancer with hormonal receptor expression that are treated with Ais. |
| No Therapy | – | Diagnostic Test: HysteroscopyPatients with previous breast cancer that are not treated with none hormonal therapies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients, divided in three groups: tamoxifen users, aromatase inhibitors users and no therapies.
Key inclusion criteria (1 listed)
- Personal history of breast cancer
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HysteroscopyAlso: Endometrial biopsyPatients with suspected endometrial pathology, will undergo hysteroscopy with endometrial biopsy or endometrial lesion excision. | Diagnostic test | Ais, No Therapy, TAM |
Primary outcome
Incidence of endometrial cancer
Time frame: One year
Evaluation of the incidence of endometrial cancer and atypical hyperplasya
1 secondary outcome
Ultrasonographic soft markers of endometrial pathology
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Cancer and Endometrial Hyperplasia With Atypia, run by Regina Elena Cancer Institute at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of endometrial cancer (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.