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

Clinical Center Kragujevac

Status: Completed

Conditions: Endometrial Carcinoma Cellular Diagnosis

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

Study type: Observational

Funder types: Other

Identifiers

NCT05951426

01119-1592

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Female

Volunteers: No 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.

Exclusion criteria

• malignant disease in the patient whose treatment is still ongoing
• pathohistological determination of atypical hyperplasia of the endometrial tissue

Trial design

60 participants in 2 patient groups

experimental group

Description:

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

Treatment:

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

control group

Description:

20 patients in whom cancer or atypical hyperplasia of the endometrium was excluded histopathologically.

Treatment:

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