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

NCT05951426 | Completed DMC

• 1 other identifier: 01119-1592
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Endometrial Carcinoma Cellular Diagnosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Relative expression COPB2 and BCL-2

  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

  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.

Study Arms (2)

experimental group

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

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

control group

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

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

Interventions

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

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Clinical Center Kragujevac: lead

MeSH Terms

Interventions

Ovariectomy

Intervention Hierarchy (Ancestors)

Castration; Endocrine Surgical Procedures; Surgical Procedures, Operative; Urogenital Surgical Procedures; Gynecologic Surgical Procedures

Study Officials

• Branko Andrić, MD

  Department for women's health care, Health Center Raska, Serbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 19, 2023
• Study Start: April 17, 2019
• Primary Completion: December 21, 2021
• Study Completion: October 1, 2022
• Last Updated: July 19, 2023

Record last verified: 2023-07