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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05951426
Enrollment
60
Registered
2023-07-19
Start date
2019-04-17
Completion date
2022-10-01
Last updated
2023-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Carcinoma Cellular Diagnosis

Keywords

Carcinoma endometrii, apoptosis, relative expression COPB2, relative expression BCL-2, Polymerase Chain Reaction

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.

Interventions

PROCEDURE1.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

Sponsors

Clinical Center Kragujevac
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
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

Design outcomes

Primary

MeasureTime frameDescription
Relative expression COPB2 and BCL-2The 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026