Endometrial Carcinoma Cellular DiagnosisNCT05951426
Expression Analysis of the COPB 2 and Bcl-2 in Early Stages of Endometrial Carcinoma
An observational study of Endometrial Carcinoma Cellular Diagnosis, run by Clinical Center Kragujevac.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Endometrial Carcinoma Cellular Diagnosis
- What is being tested?
- 1.hysterectomy with bilateral oophorectomy and pelvic lymphonodectomy. 2 explorative curettage
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 17 Apr 2019to 1 Oct 2022
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- malignant disease in the patient whose treatment is still ongoing
- pathohistological determination of atypical hyperplasia of the endometrial tissue
About this study
Official title: A Study Without a Protocol Number. Documentation Filed in the Registry Under Number 01/19/1438. Date: 08.04.2019.
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.
Read the 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.
- Conditions
- Endometrial Carcinoma Cellular Diagnosis
- Being tested
- 1.hysterectomy with bilateral oophorectomy and pelvic lymphonodectomy. 2 explorative curettage
- Keywords
- Carcinoma endometrii, apoptosis, relative expression COPB2, relative expression BCL-2, Polymerase Chain Reaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1.hysterectomy with bilateral oophorectomy and pelvic lymphonodectomy. 2 explorative curettageProcedure or surgery
- removal of the uterus with both ovaries and fallopian tubes and pelvic lymph nodes
- exploration of the uterine cavity and removal of the endometrium
| Study group | Role | What they receive |
|---|---|---|
| experimental group | 40 patients in whom Endometrial carcinoma was diagnosed as part of the experimental group. Receives: 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. Receives: Procedure: 1.hysterectomy with bilateral oophorectomy and pelvic lymphonodectomy. 2 explorative curettage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start17 Apr 2019
- Primary completion21 Dec 2021
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial Carcinoma Cellular DiagnosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Clinical Center Kragujevac
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Branko Andric, Clinical Center Kragujevac
- Investigators
- Branko Andrić, MD, Principal investigator, Department for women's health care, Health Center Raska, Serbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05951426
- Sponsor's protocol ID
- 01119-1592
- Status last verified
- Jul 2023
- First submitted
- 22 Jun 2023
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Without a Protocol Number. Documentation Filed in the Registry Under Number 01/19/1438. Date: 08.04.2019.
- ClinicalTrials.gov ID
- NCT05951426
- Acronym / sponsor ID
- 01119-1592
- Conditions
- Endometrial Carcinoma Cellular Diagnosis
- Keywords
- Carcinoma endometrii, apoptosis, relative expression COPB2, relative expression BCL-2, Polymerase Chain Reaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Clinical Center KragujevacUniversity, hospital or other
- Study start
- 17 Apr 2019 (actual)
- Primary completion
- 21 Dec 2021 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 19 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | – | Procedure: 1.hysterectomy with bilateral oophorectomy and pelvic lymphonodectomy. 2 explorative curettage40 patients in whom Endometrial carcinoma was diagnosed as part of the experimental group. |
| control group | – | Procedure: 1.hysterectomy with bilateral oophorectomy and pelvic lymphonodectomy. 2 explorative curettage20 patients in whom cancer or atypical hyperplasia of the endometrium was excluded histopathologically. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- malignant disease in the patient whose treatment is still ongoing
- pathohistological determination of atypical hyperplasia of the endometrial tissue
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1.hysterectomy with bilateral oophorectomy and pelvic lymphonodectomy. 2 explorative curettage1. 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 | Procedure or surgery | control group, experimental group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
Related trials for Endometrial Carcinoma Cellular Diagnosis
RecruitingPhase 1/2
Pembrolizumab, Lenvatinib and IL-15 Superagonist N-803 in Combination With HER2 Targeting Autologous Dendritic Cell (AdHER2DC) Vaccine in Participants With Advanced or Metastatic Endometrial Cancer
Endometrial Cancer, Cancer of Endometrium
RecruitingPhase 1
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Solid Tumor, Advanced Solid Tumor
RecruitingPhase 1
A Study of Sofe-M in Participants With Selected Advanced Solid Tumors
Ovarian Neoplasms, Endometrial Neoplasms
RecruitingPhase 2
A Phase 2 Study of Zanidatamab in Patients With HER2-expressing Tumors
Breast Cancer, Gastric Cancer
Not yet recruiting
Gut Microbiome in Patients With Lung and Melanoma Cancer and Intestinal Microbiota in Gynecologic Cancers
Non Small Cell Lung Cancer, Melanoma (Skin Cancer)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Branko Andrić, MD principal investigator
Department for women's health care, Health Center Raska, Serbia
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Carcinoma Cellular Diagnosis, run by Clinical Center Kragujevac.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2023.