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

S

Sohag University

Status

Completed

Conditions

Endometrial Adenocarcinoma
Endometrial Hyperplasia

Treatments

Other: routine stain by H&E.

Study type

Observational

Funder types

Other

Identifiers

NCT04873206
Soh-Med-21-04-29

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

Female

Ages

15+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

80 participants in 3 patient groups

Functional/ Cyclical Endometrial group.
Description:
cases of normal endometrium will be obtained from hystrectomy specimens done for causes other than hyperplasia or adenocarcinoma, for example; uterine fibroids, uterine prolapse.
Treatment:
Other: routine stain by H&E.
Hyperplastic Endometrial group.
Description:
cases of endometrial hyperplasia obtained by D\&C or hystrectomy will be stained by H\&E stain and categorized into typical or atypical hyperplasia.
Treatment:
Other: routine stain by H&E.
Primary Endometrial Adenocarcinoma group.
Description:
cases of primary endometrial adenocarcinoma obtained by D\&C or hystrectomy operations
Treatment:
Other: routine stain by H&E.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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