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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-17

Study Completion Date

2022-10-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Endometrial Carcinoma Cellular Diagnosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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experimental group

40 patients in whom Endometrial carcinoma was diagnosed as part of the experimental group.

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

Intervention Type PROCEDURE

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.

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

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No