Endometrial NeoplasmsTamAUBNCT05977829
Endometrial Malignancy in Breast Cancer Patients With or Without AUB
An observational study of Endometrial Neoplasms, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 43 to 70 years, women only
- Conditions the study is for
- Endometrial Neoplasms
- What is being tested?
- Ultrasound and Hysteroscopy
- How many people
- 283 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2020to 30 Jul 2022
- 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 43 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women undergoing gynecological examinations for endometrial surveillance related to selective estrogen receptor modulators, aromatase inhibitors or other hormone therapy for breast cancer
Who may be able to join
- 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
Who cannot join
- severe comorbidities (cardiovascular, metabolic, endocrine, and immunological disorders)
- receiving any other form of pharmacologic therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasonographic, Hysteroscopic, Histopathologic Findings and Risk of Endometrial
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.
Read the detailed description
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
- Endometrial Neoplasms
- Being tested
- Ultrasound, Hysteroscopy
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDiagnostic test
Transvaginal ultrasound to carry out uterine surveillance
HysteroscopyDiagnostic test
Outpatient hysteroscopy to carry out uterine surveillance
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer patients with abnormal uterine bleeding | * Transvaginal ultrasonography
* Outpatient Hysteroscopy Receives: Diagnostic Test: Ultrasound; Diagnostic Test: Hysteroscopy | |
| Breast cancer patients without abnormal uterine bleeding | * Transvaginal ultrasonography
* Outpatient Hysteroscopy Receives: Diagnostic Test: Ultrasound; Diagnostic Test: Hysteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endometrial cancer rate
Measured: 1 month after admission
Endometrial hyperplasia rate
Measured: 1 month after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start1 Jan 2020
- Primary completion1 Jun 2021
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial NeoplasmsStudies 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
- Retrospective
- Enrolment
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gaetano Riemma, University of Campania Luigi Vanvitelli
- Investigators
- Gaetano Riemma, MD, Principal investigator, University of Campania Luigi VanvitelliPasquale De Franciscis, MD PhD, Study chair, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05977829
- Sponsor's protocol ID
- 691
- Acronym
- TamAUB
- Status last verified
- Dec 2023
- First submitted
- 28 Jul 2023
- Last updated
- 26 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic, Hysteroscopic, Histopathologic Findings and Risk of Endometrial
- ClinicalTrials.gov ID
- NCT05977829
- Acronym / sponsor ID
- TamAUB / 691
- Conditions
- Endometrial Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 4 Aug 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.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast cancer patients with abnormal uterine bleeding | – | Diagnostic Test: Ultrasound, Diagnostic Test: Hysteroscopy* Transvaginal ultrasonography * Outpatient Hysteroscopy |
| Breast cancer patients without abnormal uterine bleeding | – | Diagnostic Test: Ultrasound, Diagnostic Test: Hysteroscopy* Transvaginal ultrasonography * Outpatient Hysteroscopy |
Who may qualify
- Ages
- 43 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women undergoing gynecological examinations for endometrial surveillance related to selective estrogen receptor modulators, aromatase inhibitors or other hormone therapy for breast cancer
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- severe comorbidities (cardiovascular, metabolic, endocrine, and immunological disorders)
- receiving any other form of pharmacologic therapy
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 |
|---|---|---|
| UltrasoundTransvaginal ultrasound to carry out uterine surveillance | Diagnostic test | Breast cancer patients with abnormal uterine bleeding, Breast cancer patients without abnormal uterine bleeding |
| HysteroscopyOutpatient hysteroscopy to carry out uterine surveillance | Diagnostic test | Breast cancer patients with abnormal uterine bleeding, Breast cancer patients without abnormal uterine bleeding |
Primary outcome
Endometrial cancer rate
Time frame: 1 month after admission
Endometrial hyperplasia rate
Time frame: 1 month after admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
Related trials for Endometrial Neoplasms
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Active, not recruitingPhase 3
Endometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line
Endometrial Cancer
RecruitingPhase 3
Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer
Advanced Endometrial Carcinoma, Recurrent Endometrial Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 3
Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer
Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
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.
Gaetano Riemma, MD principal investigator
University of Campania Luigi Vanvitelli
Pasquale De Franciscis, MD PhD study chair
University of Campania Luigi Vanvitelli
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 Neoplasms, run by University of Campania Luigi Vanvitelli 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 26 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Endometrial cancer rate (time frame: 1 month after admission). The study lists 2 primary outcomes in all. 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 26 Dec 2023.