Diagnostic and Prognostic Value of PTEN Expression in Functional and Pathological Endometrial Biopsies

July 13, 2022 updated by: Maisa Hashem Mohammed, Sohag University

Diagnostic and Prognostic Value of PTEN Expression in Functional and Pathological Endometrial Biopsies.

endometrial hyperplasia may progress to endometrial adenocarcinoma. the exact possibility of such progression is not determined. there a need to detect biological markers that can help in detecting high risk cases of patients with endometrial hyperplasia that may progress to endometrial adenocarcinoma. PTEN is a tumor suppressor gene that inhibit cell migration, proliferation and may induce apoptosis in damaged cells. variable expression of PTEN in functional, hyperplastic and neoplastic endometrial tissues may be of great help in detecting cases of hyperplasia that may progress to endometrial adenocarcinoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Adenocarcinoma of the endometrium is the most prevalent invasive tumor of female genital tract. Endometrial carcinoma is divided to 2 different types as regards to genitical and phenotypical features, type I endometrial carcinoma represents more than three quarters of all cases. Type I is inevitably preceded by hyperplastic changes in the endometrium. However, the malignant potential of endometrial hyperplasia to carcinoma is markedly variable and subjected to interobserver variations. Determine of novel biological markers for detection of precancerous endometrial hyperplasia that may proceed to endometrial adenocarcinoma is a must. PTEN is a tumor suppressor gene. it inhibits cell mitosis and migration. PTEN induce the damaged cells to pass in apoptosis. Low levels of PTEN expression noted in many human malignancies as melanoma, mammary and ovarian carcinomas.

The aim of this study is to evaluate the expression of PTEN (by immunohistochemistry) in different endometrial biological conditions as endometrial hyperplasia and primary endometrial adenocarcinoma specimens, and correlate that expression to PTEN expression in physiological endometrial specimens.

Study Type

Observational

Enrollment (Actual)

80

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

  • Egypt
      • Sohag, Egypt, 82524
        • Maisa Hashem Mohammed

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

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

endometrial specimens and hystrectomy operations will be done in Gyn&Obs Department of Sohag University Hospital and will be prepared in formalin-fixed, Parraffin-embedded blocks. endometrial blocks will be sectioned and stained by H&E stain. from the same blocks, corresponding tissue sections will be staine immunohistochemically by anti-human PTEN antibodies.

Description

Inclusion Criteria:

  • all cases of endometrial biopsies and hystrectomy specimens diagnosed as endometrial hyperplasia and/or primary endometrial adenocarcinoma.
  • all cases of normal endometrium obtained from hystrectomy specimens due to other pathological conditions as prolapsed uteri, uterine leiomyoma and adenomyosis.

Exclusion Criteria:

  • autolysed samples, very tiny specimens cervical tissues and specimens with histological picture of endometritis.

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Functional/ Cyclical Endometrial group.
cases of normal endometrium will be obtained from hystrectomy specimens done for causes other than hyperplasia or adenocarcinoma, for example; uterine fibroids, uterine prolapse.
Other: routine stain by H&E.
formalin fixed, Parraffin embedded endometrial tissues will be sectioned and get stained by the routine Haematoxalin and Eosin stain in addition to immunohistochemical staining by anti-human PTEN antibody.
Other Names:
  • Immunohistochemistry.
Hyperplastic Endometrial group.
cases of endometrial hyperplasia obtained by D&C or hystrectomy will be stained by H&E stain and categorized into typical or atypical hyperplasia.
Other: routine stain by H&E.
formalin fixed, Parraffin embedded endometrial tissues will be sectioned and get stained by the routine Haematoxalin and Eosin stain in addition to immunohistochemical staining by anti-human PTEN antibody.
Other Names:
  • Immunohistochemistry.
Primary Endometrial Adenocarcinoma group.
cases of primary endometrial adenocarcinoma obtained by D&C or hystrectomy operations
Other: routine stain by H&E.
formalin fixed, Parraffin embedded endometrial tissues will be sectioned and get stained by the routine Haematoxalin and Eosin stain in addition to immunohistochemical staining by anti-human PTEN antibody.
Other Names:
  • Immunohistochemistry.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigating the Immunohistochemical Expression of PTEN in Different Endometrial Biopsies.
Time Frame: June, 2021
cases of primary endometrial carcinoma and complex endometrial hyperplasia should express mutant form of PTEN compared to functional and simple hyperplastic endometrial tissues.
June, 2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Investigators

  • Principal Investigator: Maisa H Mohammed, MD, a lecturer of pathology, Sohag faculty of medicine

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 1, 2020

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

April 30, 2021

First Submitted That Met QC Criteria

April 30, 2021

First Posted (Actual)

May 5, 2021

Study Record Updates

Last Update Posted (Actual)

July 15, 2022

Last Update Submitted That Met QC Criteria

July 13, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-21-04-29

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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.

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