Skip to main content
OpenTrials
Completed

NCT Number: NCT05951426

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1.hysterectomy with bilateral oophorectomy and pelvic lymphonodectomy. 2 explorative curettage

Procedure
  • removal of the uterus with both ovaries and fallopian tubes and pelvic lymph nodes
  • exploration of the uterine cavity and removal of the endometrium

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Clinical Center Kragujevac

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jul 19, 2023
Registry last updated
Jul 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.