Expression Analysis of the COPB 2 and Bcl-2 in Early Stages of Endometrial Carcinoma

July 16, 2023 updated by: Branko Andric, Clinical Center Kragujevac

A Study Without a Protocol Number. Documentation Filed in the Registry Under Number 01/19/1438. Date: 08.04.2019.

COPB2 is a subunit of the intracellular transport system between cell organelles that participates in the regulation of cell division and differentiation. Bcl-2 is a protein that participates in regulating the process of apoptosis. Through the research,investigators tried to examine and establish the correlation of the expression of these two genes in endometrial cancer at an early stage.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The research was conducted as a prospective controlled clinical experimental study in the period from 2019-2022. in patients who were treated at the Gynecology and Obstetrics Clinic in Clinical Center Kragujevac. Sections of tissue deriving from the exploratory curettage and operative procedure were taken after obtaining informed consent of participants with the declaration of Helsinki and recommendations of the World Health Organization for experiments on human material and after getting approval of the Ethics Committee.

Participants are divided into two groups. Investigators stored the sample (endometrial tissue) in liquid nitrogen under adequate conditions at the Kragujevac Clinical Center, department for Gynecology and Obstetrics and examined the expression of the COPB2 and Bcl-2 gene in endometrial tissue cells of these two groups of patients. In order to examine the relative expression of the gene for the COPB2 subunit and Bcl-2, investigators sampled endometrial tissue from patients with endometrial cancer - experimental group and from patients without cancer - control group. All participants of the experimental group had initial stages of cancer, without the existence of metastases at the time of taking the sample for the study. Gene expression was performed using the Polymerase Chain Reaction method at the Faculty of Science and Mathematics in Kragujevac.

Study Type

Observational

Enrollment (Actual)

60

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The research was conducted in female patients who were treated at the Gynecology and Obstetrics Clinic in Clinical Center Kragujevac after obtaining informed consent of patients with the declaration of Helsinki and recommendations of the World Health Organization for experiments on human material and after getting approval of the Ethics Committee.

Female patients are divided into two groups:

I (first): 40 patients in whom endometrial carcinoma was diagnosed as part of the experimental group and II (second) 20 patients in whom cancer or atypical hyperplasia of the endometrium was excluded histopathologically.

Description

Inclusion Criteria:

  • signed informed consent of the patient
  • pathohistological confirmation of endometrial carcinoma for the experimental group
  • normal endometrial tissue and hyperplasia simplex endometrii for the control group.

Exclusion Criteria:

  • malignant disease in the patient whose treatment is still ongoing
  • pathohistological determination of atypical hyperplasia of the endometrial tissue

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
experimental group
40 patients in whom Endometrial carcinoma was diagnosed as part of the experimental group.
Procedure: 1.hysterectomy with bilateral oophorectomy and pelvic lymphonodectomy. 2 explorative curettage
  1. removal of the uterus with both ovaries and fallopian tubes and pelvic lymph nodes
  2. exploration of the uterine cavity and removal of the endometrium
control group
20 patients in whom cancer or atypical hyperplasia of the endometrium was excluded histopathologically.
Procedure: 1.hysterectomy with bilateral oophorectomy and pelvic lymphonodectomy. 2 explorative curettage
  1. removal of the uterus with both ovaries and fallopian tubes and pelvic lymph nodes
  2. exploration of the uterine cavity and removal of the endometrium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relative expression COPB2 and BCL-2
Time Frame: The laboratory processing of the material lasted 3 months, after all the samples were collected during the clinical part of the research. In the period from 01.03. 2022-01.06.2022.
In order to examine the relative expression of the gene for the COPB2 subunit and Bcl-2, investigators sampled endometrial tissue from patients with endometrial cancer - experimental group and from patients without cancer - control group. All patients of the experimental group had initial stages of cancer, without the existence of metastases at the time of taking the sample for the study. Gene expression was performed using the Polymerase Chain Reaction method
The laboratory processing of the material lasted 3 months, after all the samples were collected during the clinical part of the research. In the period from 01.03. 2022-01.06.2022.

Collaborators and Investigators

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

Sponsor

Clinical Center Kragujevac

Investigators

  • Principal Investigator: Branko Andrić, MD, Department for women's health care, Health Center Raska, Serbia

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)

April 17, 2019

Primary Completion (Actual)

December 21, 2021

Study Completion (Actual)

October 1, 2022

Study Registration Dates

First Submitted

June 22, 2023

First Submitted That Met QC Criteria

July 16, 2023

First Posted (Actual)

July 19, 2023

Study Record Updates

Last Update Posted (Actual)

July 19, 2023

Last Update Submitted That Met QC Criteria

July 16, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01119-1592

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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