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

Sponsor

Clinical Center Kragujevac (Other)

Overall Status

Completed

CT.gov ID

NCT05951426

Collaborator

(none)

Enrollment

41.5

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Endometrial Carcinoma Cellular Diagnosis	Procedure: 1.hysterectomy with bilateral oophorectomy and pelvic lymphonodectomy. 2 explorative curettage

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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

60 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 17, 2019

Actual Primary Completion Date :

Dec 21, 2021

Actual Study Completion Date :

Oct 1, 2022

Arms and Interventions

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

Arm

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

removal of the uterus with both ovaries and fallopian tubes and pelvic lymph nodes 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

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

Outcome Measures

Primary Outcome Measures

Relative expression COPB2 and BCL-2 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.