Immunohistochemistry Role in Better Prognosis of Endometrial Carcinoma Patients

November 27, 2023 updated by: Walid Mohamed Elnagar, Zagazig University

Stratification of Endometrial Carcinoma Patients Using Immunohistochemistry for Better Surgical Planning and Prognosis

The incidence of endometrial cancer (EC) is increasing .Different risk classifications are used to direct the primary and adjuvant therapy. The European Society for Medical Oncology - European Society of Gynaecological Oncology -European Society for Radiotherapy & Oncology (ESMO-ESGO- ESTRO) could guide the need for lymph node surgery pre-operatively, and also post-operatively to determine adjuvant treatment.

Low-risk patients are managed with surgery alone, while higher-risk group patients undergo more aggressive surgical options. So, it is important to identify new prognostic markers for better stratification of patients to avoid under- or over treatment of EC patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Ash Sharqia Governorate
      • Zagazig, Ash Sharqia Governorate, Egypt, 44519
        • Zagazig University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • aged 36 -72 years;
  • Previously diagnosed with endometrial carcinoma;
  • Histological Type of the tumor;
  • Myometrial Invasion;
  • lymph Node Invasion;
  • Cervical Invasion;
  • Biomarkers expression.

Exclusion Criteria:

  • Lack of tumor tissue in tissue block

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Study group
Diagnostic test: Tissue Biopsy
The Post-hysterectomy tissue biopsy was analyzed immunohistochemically for detection of estrogen and progesterone receptors, P53 and L1CAM
No Intervention: Excluded Patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
expression levels of p53/L1CAM/ER/PR
Time Frame: 36 Months
The Prognostic value of immunohistochemical detection of expression levels of p53/L1CAM/ER/PR in relation to ESMO-ESGO-ESTRO risk groups
36 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2019

Primary Completion (Actual)

October 1, 2021

Study Completion (Actual)

March 1, 2022

Study Registration Dates

First Submitted

November 13, 2023

First Submitted That Met QC Criteria

November 27, 2023

First Posted (Actual)

November 28, 2023

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZU-IRB#10903-21/6-2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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