Immunohistochemistry Role in Better Prognosis of Endometrial Carcinoma Patients

Sponsor

Zagazig University (Other)

Overall Status

Completed

CT.gov ID

NCT06148129

Collaborator

(none)

Enrollment

Location

Arms

37.6

Actual Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Endometrial Cancer	Diagnostic Test: Tissue Biopsy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

96 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 12, 2019

Actual Primary Completion Date :

Oct 1, 2021

Actual Study Completion Date :

Mar 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

expression levels of p53/L1CAM/ER/PR [36 Months]
The Prognostic value of immunohistochemical detection of expression levels of p53/L1CAM/ER/PR in relation to ESMO-ESGO-ESTRO risk groups

Eligibility Criteria

Criteria

Ages Eligible for Study:

36 Years to 72 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zagazig university	Zagazig	Ash Sharqia Governorate	Egypt	44519

Sponsors and Collaborators

Zagazig University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Walid Mohamed Elnagar, Assistant professor of gynecology, Zagazig University

ClinicalTrials.gov Identifier:

NCT06148129

Other Study ID Numbers:

ZU-IRB#10903-21/6-2023

First Posted:

Nov 28, 2023

Last Update Posted:

Nov 28, 2023

Last Verified:

Nov 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Endometrial Neoplasms

Study Results

No Results Posted as of Nov 28, 2023