Autophagy Markers in Endometrial Polyps

Sponsor
Muğla Sıtkı Koçman University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04706000
Collaborator
(none)
30
1
12.8
2.3

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Genetic: Beclin 1 gene

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 Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Investigation of Autophagy Markers in Endometrial Polyps
Anticipated Study Start Date :
Jan 8, 2021
Anticipated Primary Completion Date :
Jan 8, 2022
Anticipated Study Completion Date :
Feb 1, 2022

Arms and Interventions

Arm 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
  • Outcome Measures

    Primary Outcome Measures

    1. autophagy marker [through study completion, an average of 1 year]

      Beclin 1 gene level

    2. autophagy marker [through study completion, an average of 1 year]

      LC3II gene level

    3. autophagy marker [through study completion, an average of 1 year]

      p62 gene level

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mugla Sıtkı Kocman University Faculty of Medicine Muğla Turkey 48000

    Sponsors and Collaborators

    • Muğla Sıtkı Koçman University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Burak Sezgin, Principal investigator M.D. Burak Sezgin, Muğla Sıtkı Koçman University
    ClinicalTrials.gov Identifier:
    NCT04706000
    Other Study ID Numbers:
    • 03.09.20-08/01
    First Posted:
    Jan 12, 2021
    Last Update Posted:
    Jan 12, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Burak Sezgin, Principal investigator M.D. Burak Sezgin, Muğla Sıtkı Koçman University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 12, 2021