Clinical trial NCT05951426: Expression Analysis of the COPB 2 and Bcl-2 in Early Stages of Endometrial Carcinoma
Official title: A Study Without a Protocol Number. Documentation Filed in the Registry Under Number 01/19/1438. Date: 08.04.2019.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometrial Carcinoma Cellular Diagnosis
Keywords: Carcinoma endometrii
apoptosis
relative expression COPB2
relative expression BCL-2
Polymerase Chain Reaction
Lead sponsor: Clinical Center Kragujevac
Sponsor class: OTHER
First posted: 2023-07-19
Enrollment: 60
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The research was conducted in female patients who were treated at the Gynecology and Obstetrics Clinic in Clinical Center Kragujevac after obtaining informed consent of patients 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.

Female patients are divided into two groups:

I (first): 40 patients in whom endometrial carcinoma was diagnosed as part of the experimental group and II (second) 20 patients in whom cancer or atypical hyperplasia of the endometrium was excluded histopathologically.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Relative expression COPB2 and BCL-2
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department for women's health care, Health Center Raska, Serbia
name: Branko Andrić, MD
role: PRINCIPAL_INVESTIGATOR
References: