Immunohistochemistry Role in Better Prognosis of Endometrial Carcinoma Patients

Endometrial Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06148129
• Other study ID #: ZU-IRB#10903-21/6-2023
• Status: Completed
• Phase: N/A
• Start date: January 12, 2019
• Est. completion date: March 1, 2022

Study information

• Verified date: November 2023
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: March 1, 2022
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 36 Years to 72 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Diagnostic Test:
• Tissue Biopsy
The Post-hysterectomy tissue biopsy was analyzed immunohistochemically for detection of estrogen and progesterone receptors, P53 and L1CAM

Locations

Country	Name	City	State
Egypt	Zagazig university	Zagazig	Ash Sharqia Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	expression levels of p53/L1CAM/ER/PR	The Prognostic value of immunohistochemical detection of expression levels of p53/L1CAM/ER/PR in relation to ESMO-ESGO-ESTRO risk groups	36 Months