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

NCT04873206 | Completed

• 1 other identifier: Soh-Med-21-04-29
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrial Hyperplasia; Endometrial Adenocarcinoma

Keywords

PTEN.; Endometrial Hyperplasia.; Endometrial Carcinoma

Outcome Measures

Primary Outcomes (1)

• Investigating the Immunohistochemical Expression of PTEN in Different Endometrial Biopsies.

  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

Study Arms (3)

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.

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.

Primary Endometrial Adenocarcinoma group.

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

Other: routine stain by H&E.

Interventions

routine stain by H&E. 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.

Also known as: Immunohistochemistry.

Functional/ Cyclical Endometrial group.; Hyperplastic Endometrial group.; Primary Endometrial Adenocarcinoma group.

Eligibility Criteria

• Age: 15 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Maisa Hashem Mohammed

Sohag, 82524, Egypt

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

specimens fixed in Formalin and embedded in Parraffin

MeSH Terms

Conditions

Endometrial Hyperplasia; Endometrial Neoplasms

Interventions

Immunohistochemistry

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques

Study Officials

• Maisa H Mohammed, MD

  a lecturer of pathology, Sohag faculty of medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of pathology

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 5, 2021
• Study Start: January 1, 2020
• Primary Completion: June 30, 2020
• Study Completion: December 31, 2020
• Last Updated: July 15, 2022

Record last verified: 2022-07

Locations

EG (1)