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

NCT ID: NCT04873206

Last Updated: 2022-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Endometrial Hyperplasia Endometrial Adenocarcinoma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

routine stain by H&E.

Intervention Type OTHER

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.

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.

routine stain by H&E.

Intervention Type OTHER

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.

Primary Endometrial Adenocarcinoma group.

cases of primary endometrial adenocarcinoma obtained by D\&C or hystrectomy operations

routine stain by H&E.

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Immunohistochemistry.

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Maisa Hashem Mohammed

lecturer of pathology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maisa H Mohammed, MD

Role: PRINCIPAL_INVESTIGATOR

a lecturer of pathology, Sohag faculty of medicine

Locations

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Maisa Hashem Mohammed

Sohag, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Soh-Med-21-04-29

Identifier Type: -

Identifier Source: org_study_id

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