Autophagy Markers in Endometrial Polyps

Endometrial Polyp Clinical Trial

Official title:

Investigation of Autophagy Markers in Endometrial Polyps

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04706000
• Other study ID #: 03.09.20-08/01
• Status: Completed
• Start date: January 8, 2021
• Est. completion date: February 1, 2022

Study information

• Verified date: December 2023
• Source: Mugla Sitki Koçman University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 1, 2022
• Est. primary completion date: January 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Autophagy
• Endometrial Polyp
• Polyps
• Uterine Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Turkey	Mugla Sitki Kocman University Faculty of Medicine	Mugla

Sponsors (1)

Lead Sponsor	Collaborator
Mugla Sitki Koçman University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View Citation

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

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. — View Citation

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. — View Citation

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 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	autophagy marker	Beclin 1 gene level	through study completion, an average of 1 year
Primary	autophagy marker	LC3II gene level	through study completion, an average of 1 year
Primary	autophagy marker	p62 gene level	through study completion, an average of 1 year