Autophagy Markers in Endometrial Polyps

December 5, 2023 updated by: Burak Sezgin, Muğla Sıtkı Koçman University

Investigation of Autophagy Markers in Endometrial Polyps

The aim of this research is to evaluate autophagy markers in patients with endometrial polyps

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Endometrial polyp are benign formations that are frequently encountered in gynecology practice and have malignant potential. It may be asymptomatic in the clinic or may present with abnormal uterine bleeding. Although its pathophysiology has not been clearly revealed, there are many studies in the literature about it. However, the autophagy pathway emerges as a subject that has never been evaluated. In this study, the investigators would like to prospectively evaluate Beclin 1, LC3A / B and p62 markers in the autophagy pathway in endometrial polyp tissue samples by immunohistochemistry and reveal their importance.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Muğla, Turkey, 48000
        • Mugla Sıtkı Kocman University Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patients with histopathologically proven endometrial polyp and healthy controls

Description

Inclusion Criteria:

  • Patients over 35 years of age with a histopathologically confirmed diagnosis of endometrial polyp
  • patients over the age of 35 whose histopathologically reported normal endometrial biopsy results.

Exclusion Criteria:

  • Are under the age of 35,
  • those with cognitive dysfunction,
  • diagnosed with any type of cancer
  • who are under treatment for cancer,
  • diabetes mellitus,
  • hypertension,
  • endometriosis,
  • adenomyosis,
  • chronic endometritis,
  • have an acute or chronic illness,
  • patients who have smoked and used alcohol in the last 10 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study group
endometrial polyp
Genetic: Beclin 1 gene
The determination of Beclin 1, LC3-II and p62 genes, which are evaluated by immunohistochemistry, at the protein level will be done by ELISA method in MSKU Medical Faculty Medical Biology Laboratory.
Other Names:
  • LC3-II gene
  • p62 gene
Control group
normal endometrium
Genetic: Beclin 1 gene
The determination of Beclin 1, LC3-II and p62 genes, which are evaluated by immunohistochemistry, at the protein level will be done by ELISA method in MSKU Medical Faculty Medical Biology Laboratory.
Other Names:
  • LC3-II gene
  • p62 gene

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
autophagy marker
Time Frame: through study completion, an average of 1 year
Beclin 1 gene level
through study completion, an average of 1 year
autophagy marker
Time Frame: through study completion, an average of 1 year
LC3II gene level
through study completion, an average of 1 year
autophagy marker
Time Frame: through study completion, an average of 1 year
p62 gene level
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Muğla Sıtkı Koçman University

Investigators

  • Principal Investigator: Burak SEZGİN, MD, Muğla Sıtkı Koçman University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2021

Primary Completion (Actual)

January 8, 2022

Study Completion (Actual)

February 1, 2022

Study Registration Dates

First Submitted

January 8, 2021

First Submitted That Met QC Criteria

January 11, 2021

First Posted (Actual)

January 12, 2021

Study Record Updates

Last Update Posted (Estimated)

December 6, 2023

Last Update Submitted That Met QC Criteria

December 5, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03.09.20-08/01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

When we conducted the study, we will plan to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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