NCT04706000

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

January 8, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 12, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2022

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

December 6, 2023

Status Verified

December 1, 2023

Enrollment Period

1 year

First QC Date

January 8, 2021

Last Update Submit

December 5, 2023

Conditions

Endometrial PolypAutophagy

Keywords

polypendometriumbeclin 1LC3p62

Outcome Measures

Primary Outcomes (3)

  • autophagy marker

    Beclin 1 gene level

    through study completion, an average of 1 year

  • autophagy marker

    LC3II gene level

    through study completion, an average of 1 year

  • autophagy marker

    p62 gene level

    through study completion, an average of 1 year

Study Arms (2)

Study group

endometrial polyp

Genetic: Beclin 1 gene

Control group

normal endometrium

Genetic: Beclin 1 gene

Interventions

Beclin 1 geneGENETIC

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.

Also known as: LC3-II gene, p62 gene
Control groupStudy group

Eligibility Criteria

Age35 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsendometrial polyp
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with histopathologically proven endometrial polyp and healthy controls

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mugla Sıtkı Kocman University Faculty of Medicine

Muğla, 48000, Turkey (Türkiye)

Location

Related Publications (5)

  • Zhang J. Teaching the basics of autophagy and mitophagy to redox biologists--mechanisms and experimental approaches. Redox Biol. 2015;4:242-59. doi: 10.1016/j.redox.2015.01.003. Epub 2015 Jan 13.

    PMID: 25618581BACKGROUND

  • Zhan L, Yao S, Sun S, Su Q, Li J, Wei B. NLRC5 and autophagy combined as possible predictors in patients with endometriosis. Fertil Steril. 2018 Oct;110(5):949-956. doi: 10.1016/j.fertnstert.2018.06.028.

    PMID: 30316442BACKGROUND

  • Xie Z, Klionsky DJ. Autophagosome formation: core machinery and adaptations. Nat Cell Biol. 2007 Oct;9(10):1102-9. doi: 10.1038/ncb1007-1102.

    PMID: 17909521BACKGROUND

  • Wong M, Crnobrnja B, Liberale V, Dharmarajah K, Widschwendter M, Jurkovic D. The natural history of endometrial polyps. Hum Reprod. 2017 Feb;32(2):340-345. doi: 10.1093/humrep/dew307. Epub 2016 Dec 18.

    PMID: 27994000BACKGROUND

  • Zhang L, Liu Y, Xu Y, Wu H, Wei Z, Cao Y. The expression of the autophagy gene beclin-1 mRNA and protein in ectopic and eutopic endometrium of patients with endometriosis. Int J Fertil Steril. 2015 Jan-Mar;8(4):429-36. doi: 10.22074/ijfs.2015.4183. Epub 2015 Feb 7.

    PMID: 25780525RESULT

MeSH Terms

Conditions

Polyps

Interventions

Beclin-1

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Apoptosis Regulatory ProteinsIntracellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsAutophagy-Related ProteinsProteins

Study Officials

  • Burak SEZGİN, MD

    Muğla Sıtkı Koçman University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator M.D. Burak Sezgin

Study Record Dates

First Submitted

January 8, 2021

First Posted

January 12, 2021

Study Start

January 8, 2021

Primary Completion

January 8, 2022

Study Completion

February 1, 2022

Last Updated

December 6, 2023

Record last verified: 2023-12

Locations

TU(1)