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

• Sponsor: Sohag University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04873206
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Actual Duration (Months): 12
• Patients Per Site Per Month: 6.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endometrial Hyperplasia; Endometrial Adenocarcinoma	Other: routine stain by H&E.

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 Design

• Study Type: Observational
• Actual Enrollment: 80 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Diagnostic and Prognostic Value of PTEN Expression in Functional and Pathological Endometrial Biopsies.
• Actual Study Start Date: Jan 1, 2020
• Actual Primary Completion Date: Jun 30, 2020
• Actual Study Completion Date: Dec 31, 2020

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Investigating the Immunohistochemical Expression of PTEN in Different Endometrial Biopsies. [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maisa Hashem Mohammed	Sohag		Egypt	82524

Sponsors and Collaborators

• Sohag University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maisa Hashem Mohammed, lecturer of pathology, Sohag University
• ClinicalTrials.gov Identifier: NCT04873206
• Other Study ID Numbers: Soh-Med-21-04-29
• First Posted: May 5, 2021
• Last Update Posted: Jul 15, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Maisa Hashem Mohammed, lecturer of pathology, Sohag University: PTEN.; Endometrial Hyperplasia.; Endometrial Carcinoma
• Additional relevant MeSH terms: Endometrial Hyperplasia; Hyperplasia

Study Results

No Results Posted as of Jul 15, 2022