Correlation Between Hysteroscopic Diagnosis of Endometrial Hyperplasia and Histopathological Examination

NCT03917147 | Completed

• 1 other identifier: N.592
• Study Type: observational
• Target: 435
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Endometrial Hyperplasia; Endometrial Neoplasms

Keywords

Endometrial Hyperplasia; Office Hysteroscopy; Predictive values; Sensitivity

Outcome Measures

Primary Outcomes (2)

• Sensitivity For Endometrial Hyperplasia

  12 months

• Correlation between histopathological and cllinical diagnosis for Endometrial Hyperplasia

  12 months

Secondary Outcomes (4)

• Negative Predictive value

  12 months

• Positive Predictive value

  12 months

• Likelihood ratio

  12 months

• Positive and negative post test probability

  12 months

Study Arms (4)

AUB in Post-Menopause

Abnormal Uterine Bleeding (AUB) in Post-Menopause

Procedure: Office Hysteroscopy

Endometrial Thickening in post-menopause

Ultrasonographic detection of Thickened Endometrium in post-menopause

Procedure: Office Hysteroscopy

Endometrial Thickening in pre-menopause

Ultrasonographic detection of Thickened Endometrium in pre-menopause

Procedure: Office Hysteroscopy

Pharmacological history of Tamoxifen-related therapy regimens

Patients who had been treated with Tamoxifen

Procedure: Office Hysteroscopy

Interventions

Office Hysteroscopy PROCEDURE

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.

AUB in Post-Menopause; Endometrial Thickening in post-menopause; Endometrial Thickening in pre-menopause; Pharmacological history of Tamoxifen-related therapy regimens

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women included in this study are referred by gynaecologists of the general outpatient rooms of the institution's hospital

You may qualify if:

• 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

You may not qualify if:

• severe urinary symptoms
• history of severe comorbidities (autoimmune disorders, chronic diseases and severe cardiac disease)

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli"

Naples, 80131, Italy

Location

Related Publications (4)

• 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.

  PMID: 29219004 BACKGROUND

• Trimble 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.

  PMID: 16400639 BACKGROUND

• Bourdel 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.

  PMID: 27058769 BACKGROUND

• De 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.

  PMID: 31591361 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Endometrial Biopsy

MeSH Terms

Conditions

Endometrial Hyperplasia; Endometrial Neoplasms; Hypersensitivity

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 12, 2019
• First Posted: April 16, 2019
• Study Start: January 8, 2018
• Primary Completion: October 18, 2018
• Study Completion: December 9, 2018
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)