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Clinical Trials/NCT05951426
NCT05951426CompletedNot Applicable

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

Clinical Center Kragujevac0 sites60 target enrollmentStarted: April 17, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
60
Primary Endpoint
Relative expression COPB2 and BCL-2

Study Overview

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.

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
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
Female
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Clinical Center Kragujevac
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Branko Andric

Principal investigator

Clinical Center Kragujevac

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