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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
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.
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
experimental group
40 patients in whom Endometrial carcinoma was diagnosed as part of the experimental group.
|
|
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control group
20 patients in whom cancer or atypical hyperplasia of the endometrium was excluded histopathologically.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Relative expression COPB2 and BCL-2
Time Frame: 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.
|
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.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Branko Andrić, MD, Department for women's health care, Health Center Raska, Serbia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Carcinoma
- Endometrial Neoplasms
Other Study ID Numbers
- 01119-1592
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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