Endometrial HyperplasiaNCT03917147
Correlation Between Hysteroscopic Diagnosis of Endometrial Hyperplasia and Histopathological Examination
An observational study of Endometrial Hyperplasia and Endometrial Neoplasms, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial summary
A prospective cohort study at a Tertiary University Hospital. From January to December 2018, we enrolled women with the following criteria: abnormal uterine bleeding in post-menopause, endometrial thickening in pre-or post-menopause; tamoxifen usage. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Endometrial Hyperplasia, Endometrial Neoplasms
- What is being tested?
- Office Hysteroscopy
- Type of treatment
- Surgery or procedure
- How many people
- 435 participants
- Where
- 1 siteItaly
- Study dates
- 8 Jan 2018to 9 Dec 2018
- 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 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: Women included in this study are referred by gynaecologists of the general outpatient rooms of the institution's hospital
Who may be able to join
- abnormal uterine bleeding in post-menopause
- ultrasonographic detection of endometrial thickening in pre-menopause
- ultrasonographic detection of endometrial thickening in post-menopause
- follow-up after Tamoxifen-based therapy regimens
Who cannot join
- severe urinary symptoms
- history of severe comorbidities (autoimmune disorders, chronic diseases and severe cardiac disease)
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli"
Naples, 80131
About this study
Official title: Correlation Between Hysteroscopic Diagnosis of Endometrial Hyperplasia and Histopathological Examination: a Prospective Cohort Study
A prospective cohort study at a Tertiary University Hospital. From January to December 2018, we enrolled women with the following criteria: abnormal uterine bleeding in post-menopause, endometrial thickening in pre-or post-menopause; tamoxifen usage. Patients underwent office hysteroscopy with a 5-mm continuous-flow hysteroscope and endometrial biopsies were taken using miniaturized instruments. Senior operators had to foresee histopathological diagnosis using a questionnaire. Histopathological examination was conducted to confirm the diagnosis.
Read the detailed description
Patient underwent the procedure after the menstrual phase (day 6 to 10) of a spontaneous menstrual cycle. All the procedures were performed by means of a continuous flow small-diameter hysteroscope with oval profile (maximum diameter 5 mm, minimum diameter 3.9 mm) (Bettocchi Office Hysteroscope size 5, Karl Storz GmbH \& Co., Tuttlingen, Germany) fitted with a 30-degree telescope of 2.9 mm gauge, using the vaginoscopic approach, without tenaculum and speculum, and using saline solution as distending medium at 90-100 mmHg pressure generated by a pneumatic cuff and measured by means of a manometer; the biopsies were performed with the "punch" or "grasp" technique using a 5 Fr grasping forceps inserted through the operating channel of the hysteroscope. In case of small intrauterine pathologies, they were easily removed by means of a straight bipolar electrode active by an electrosurgical generator (Versapoint II; Gynecare, Ethicon) used to provide a 50W power for the mildest vapour cutting mode (VC3).
The hysteroscopic diagnosis of hyperplasia was based on one or more of the following findings: (1) focal or diffuse, papillary or polypoid, endometrial thickening, (2) Abnormal vascular patterns; (3) evidence of glandular cysts; (4) abnormal architecture features of glandular outlets (thickening, irregular gland density, dilatation). Although no consensus or RCTs showed agreement in describing objective criteria for EH, several trials agreed on the previous morphologic evaluation. [8].
The procedures were taken by three senior gynaecologists (P.D.F, L.C., N.C) whose expertise and skills were equivalent. After every procedure, surgeons were asked to propose a suggestive histological categorization of the clinical diagnosis by means of a questionnaire, in order to standardize the assessment. The questionnaire was made of a progressive number which identified the biopsy and a multiple-choice question. Operators were asked to choose one from the following answers: Benign (including atrophic endometrium, proliferative endometrium, endometrial polyp/s); Endometrial Hyperplasia (simple or complex hyperplasia); Atypical Hyperplasia/Carcinoma (including atypical endometrial hyperplasia and adenocarcinoma) Biopsied histological samples were sent for histopathological analysis. The histopathological examination of all the specimens was performed at the Pathology Unit of University of Campania "Luigi Vanvitelli". Three senior gynecopathologists (INS), with the same skills and expertise, were addressed to evaluate all the biopsies
- Conditions
- Endometrial Hyperplasia, Endometrial Neoplasms
- Being tested
- Office Hysteroscopy
- Keywords
- Endometrial Hyperplasia, Office Hysteroscopy, Predictive values, Sensitivity
- Medical subject headings
- Endometrial Hyperplasia, Endometrial Neoplasms, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Office HysteroscopyProcedure or surgery
Patients underwent office hysteroscopy with a 5-mm continuous-flow hysteroscope and endometrial biopsies were taken using miniaturized instruments. Histopathological examination was conducted to confirm the diagnosis.
| Study group | Role | What they receive |
|---|---|---|
| AUB in Post-Menopause | Abnormal Uterine Bleeding (AUB) in Post-Menopause Receives: Procedure: Office Hysteroscopy | |
| Endometrial Thickening in post-menopause | Ultrasonographic detection of Thickened Endometrium in post-menopause Receives: Procedure: Office Hysteroscopy | |
| Endometrial Thickening in pre-menopause | Ultrasonographic detection of Thickened Endometrium in pre-menopause Receives: Procedure: Office Hysteroscopy | |
| Pharmacological history of Tamoxifen-related therapy regimens | Patients who had been treated with Tamoxifen Receives: Procedure: Office Hysteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity For Endometrial Hyperplasia
Measured: 12 months
Correlation between histopathological and cllinical diagnosis for Endometrial Hyperplasia
Measured: 12 months
Secondary outcomes (4)
Negative Predictive value
Measured: 12 months
Positive Predictive value
Measured: 12 months
Likelihood ratio
Measured: 12 months
Positive and negative post test probability
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start8 Jan 2018
- Primary completion18 Oct 2018
- Study completion9 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Endometrial HyperplasiaStudies 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
- 435 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Pasquale De Franciscis, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03917147
- Sponsor's protocol ID
- N.592
- Status last verified
- Apr 2023
- First submitted
- 12 Apr 2019
- Last updated
- 12 Apr 2023
- Results posted
- No
- Individual data sharing
- No
Publications
Ghoubara A, Sundar S, Ewies AAA. Predictors of malignancy in endometrial polyps: study of 421 women with postmenopausal bleeding. Climacteric. 2018 Feb;21(1):82-87. doi: 10.1080/13697137.2017.1410783. Epub 2017 Dec 8.
PubMed 29219004Trimble CL, Kauderer J, Zaino R, Silverberg S, Lim PC, Burke JJ 2nd, Alberts D, Curtin J. Concurrent endometrial carcinoma in women with a biopsy diagnosis of atypical endometrial hyperplasia: a Gynecologic Oncology Group study. Cancer. 2006 Feb 15;106(4):812-9. doi: 10.1002/cncr.21650.
PubMed 16400639Bourdel N, Chauvet P, Tognazza E, Pereira B, Botchorishvili R, Canis M. Sampling in Atypical Endometrial Hyperplasia: Which Method Results in the Lowest Underestimation of Endometrial Cancer? A Systematic Review and Meta-analysis. J Minim Invasive Gynecol. 2016 Jul-Aug;23(5):692-701. doi: 10.1016/j.jmig.2016.03.017. Epub 2016 Apr 4.
PubMed 27058769De Franciscis P, Riemma G, Schiattarella A, Cobellis L, Guadagno M, Vitale SG, Mosca L, Cianci A, Colacurci N. Concordance between the Hysteroscopic Diagnosis of Endometrial Hyperplasia and Histopathological Examination. Diagnostics (Basel). 2019 Oct 7;9(4):142. doi: 10.3390/diagnostics9040142.
PubMed 31591361
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Hysteroscopic Diagnosis of Endometrial Hyperplasia and Histopathological Examination: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03917147
- Acronym / sponsor ID
- N.592
- Conditions
- Endometrial Hyperplasia, Endometrial Neoplasms
- Keywords
- Endometrial Hyperplasia, Office Hysteroscopy, Predictive values, Sensitivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 435 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 18 Oct 2018 (actual)
- Study completion
- 9 Dec 2018 (actual)
- First posted
- 16 Apr 2019 (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.
A prospective cohort study at a Tertiary University Hospital. From January to December 2018, we enrolled women with the following criteria: abnormal uterine bleeding in post-menopause, endometrial thickening in pre-or post-menopause; tamoxifen usage. Patients underwent office hysteroscopy with a 5-mm continuous-flow hysteroscope and endometrial biopsies were taken using miniaturized instruments. Senior operators had to foresee histopathological diagnosis using a questionnaire. Histopathological examination was conducted to confirm the diagnosis.
Detailed description
Patient underwent the procedure after the menstrual phase (day 6 to 10) of a spontaneous menstrual cycle. All the procedures were performed by means of a continuous flow small-diameter hysteroscope with oval profile (maximum diameter 5 mm, minimum diameter 3.9 mm) (Bettocchi Office Hysteroscope size 5, Karl Storz GmbH \& Co., Tuttlingen, Germany) fitted with a 30-degree telescope of 2.9 mm gauge, using the vaginoscopic approach, without tenaculum and speculum, and using saline solution as distending medium at 90-100 mmHg pressure generated by a pneumatic cuff and measured by means of a manometer; the biopsies were performed with the "punch" or "grasp" technique using a 5 Fr grasping forceps inserted through the operating channel of the hysteroscope. In case of small intrauterine pathologies, they were easily removed by means of a straight bipolar electrode active by an electrosurgical generator (Versapoint II; Gynecare, Ethicon) used to provide a 50W power for the mildest vapour cutting mode (VC3).
The hysteroscopic diagnosis of hyperplasia was based on one or more of the following findings: (1) focal or diffuse, papillary or polypoid, endometrial thickening, (2) Abnormal vascular patterns; (3) evidence of glandular cysts; (4) abnormal architecture features of glandular outlets (thickening, irregular gland density, dilatation). Although no consensus or RCTs showed agreement in describing objective criteria for EH, several trials agreed on the previous morphologic evaluation. [8].
The procedures were taken by three senior gynaecologists (P.D.F, L.C., N.C) whose expertise and skills were equivalent. After every procedure, surgeons were asked to propose a suggestive histological categorization of the clinical diagnosis by means of a questionnaire, in order to standardize the assessment. The questionnaire was made of a progressive number which identified the biopsy and a multiple-choice question. Operators were asked to choose one from the following answers: Benign (including atrophic endometrium, proliferative endometrium, endometrial polyp/s); Endometrial Hyperplasia (simple or complex hyperplasia); Atypical Hyperplasia/Carcinoma (including atypical endometrial hyperplasia and adenocarcinoma) Biopsied histological samples were sent for histopathological analysis. The histopathological examination of all the specimens was performed at the Pathology Unit of University of Campania "Luigi Vanvitelli". Three senior gynecopathologists (INS), with the same skills and expertise, were addressed to evaluate all the biopsies
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AUB in Post-Menopause | – | Procedure: Office HysteroscopyAbnormal Uterine Bleeding (AUB) in Post-Menopause |
| Endometrial Thickening in post-menopause | – | Procedure: Office HysteroscopyUltrasonographic detection of Thickened Endometrium in post-menopause |
| Endometrial Thickening in pre-menopause | – | Procedure: Office HysteroscopyUltrasonographic detection of Thickened Endometrium in pre-menopause |
| Pharmacological history of Tamoxifen-related therapy regimens | – | Procedure: Office HysteroscopyPatients who had been treated with Tamoxifen |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women included in this study are referred by gynaecologists of the general outpatient rooms of the institution's hospital
Key inclusion criteria (4 listed)
- abnormal uterine bleeding in post-menopause
- ultrasonographic detection of endometrial thickening in pre-menopause
- ultrasonographic detection of endometrial thickening in post-menopause
- follow-up after Tamoxifen-based therapy regimens
Key exclusion criteria (2 listed)
- severe urinary symptoms
- history of severe comorbidities (autoimmune disorders, chronic diseases and severe cardiac disease)
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 |
|---|---|---|
| Office HysteroscopyPatients underwent office hysteroscopy with a 5-mm continuous-flow hysteroscope and endometrial biopsies were taken using miniaturized instruments. Histopathological examination was conducted to confirm the diagnosis. | Procedure or surgery | AUB in Post-Menopause, Endometrial Thickening in post-menopause, Endometrial Thickening in pre-menopause, Pharmacological history of Tamoxifen-related therapy regimens |
Primary outcome
Sensitivity For Endometrial Hyperplasia
Time frame: 12 months
Correlation between histopathological and cllinical diagnosis for Endometrial Hyperplasia
Time frame: 12 months
4 secondary outcomes
Negative Predictive value
Time frame: 12 months
Positive Predictive value
Time frame: 12 months
Likelihood ratio
Time frame: 12 months
Positive and negative post test probability
Time frame: 12 months
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 12 Apr 2023.
- Background: PubMed 29219004Ghoubara A, Sundar S, Ewies AAA. Predictors of malignancy in endometrial polyps: study of 421 women with postmenopausal bleeding. Climacteric. 2018 Feb;21(1):82-87. doi: 10.1080/13697137.2017.1410783. Epub 2017 Dec 8.
- Background: PubMed 16400639Trimble CL, Kauderer J, Zaino R, Silverberg S, Lim PC, Burke JJ 2nd, Alberts D, Curtin J. Concurrent endometrial carcinoma in women with a biopsy diagnosis of atypical endometrial hyperplasia: a Gynecologic Oncology Group study. Cancer. 2006 Feb 15;106(4):812-9. doi: 10.1002/cncr.21650.
- Background: PubMed 27058769Bourdel N, Chauvet P, Tognazza E, Pereira B, Botchorishvili R, Canis M. Sampling in Atypical Endometrial Hyperplasia: Which Method Results in the Lowest Underestimation of Endometrial Cancer? A Systematic Review and Meta-analysis. J Minim Invasive Gynecol. 2016 Jul-Aug;23(5):692-701. doi: 10.1016/j.jmig.2016.03.017. Epub 2016 Apr 4.
- Derived from this study: PubMed 31591361De Franciscis P, Riemma G, Schiattarella A, Cobellis L, Guadagno M, Vitale SG, Mosca L, Cianci A, Colacurci N. Concordance between the Hysteroscopic Diagnosis of Endometrial Hyperplasia and Histopathological Examination. Diagnostics (Basel). 2019 Oct 7;9(4):142. doi: 10.3390/diagnostics9040142.
- Individual participant dataSharing planned: No
Related trials for Endometrial Hyperplasia
RecruitingObservational study
Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer
Endometrial Cancer, Cervical Cancer
Active, not recruitingPhase 2
Levonorgestrel-Releasing Intrauterine System in Treating Patients With Complex Atypical Hyperplasia or Grade I Endometrial Cancer
Atypical Endometrial Hyperplasia, Stage I Uterine Corpus Cancer AJCC v7
RecruitingObservational study
Liquid Biopsy-Based Early Screening for Endometrial Cancer in Regional Chinese Populations
Endometrial Cancer, Atypical Endometrial Hyperplasia
Not yet recruitingPhase 2
Canagliflozin Plus Progestin for Atypical Endometrial Hyperplasia and Early-Stage Endometrial Cancer
Endometrioid Endometrial Cancer, Atypical Endometrial Hyperplasia
RecruitingPhase 2
A Study to Estimate Early Clinical Efficacy Signals of GLP-1 Agonist Administration in Conjunction With Levonorgestrel Intrauterine Device in Obese Patients With Endometrioid Intraepithelial Neoplasia
Endometrioid Endometrial Adenocarcinoma
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 Hyperplasia and 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 4 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 12 Apr 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?
Sensitivity For Endometrial Hyperplasia (time frame: 12 months). 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?
On the ClinicalTrials.gov record for NCT03917147, which also lists 4 linked publications.
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 12 Apr 2023.