Clinical trial NCT04873206: Diagnostic and Prognostic Value of PTEN Expression in Functional and Pathological Endometrial Biopsies
Official title: Diagnostic and Prognostic Value of PTEN Expression in Functional and Pathological Endometrial Biopsies.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometrial Hyperplasia
Endometrial Adenocarcinoma
Keywords: PTEN.
Endometrial Hyperplasia.
Endometrial Carcinoma
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-05-05
Enrollment: 80
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Investigating the Immunohistochemical Expression of PTEN in Different Endometrial Biopsies.
timeFrame: June, 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Maisa Hashem Mohammed
Study officials:
affiliation: a lecturer of pathology, Sohag faculty of medicine
name: Maisa H Mohammed, MD
role: PRINCIPAL_INVESTIGATOR
References: