Clinical trial NCT04706000: Autophagy Markers in Endometrial Polyps
Official title: Investigation of Autophagy Markers in Endometrial Polyps
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometrial Polyp
Autophagy
Keywords: polyp
endometrium
beclin 1
LC3
p62
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2021-01-12
Enrollment: 30
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with histopathologically proven endometrial polyp and healthy controls

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: autophagy marker
timeFrame: through study completion, an average of 1 year
measure: autophagy marker
timeFrame: through study completion, an average of 1 year
measure: autophagy marker
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Muğla
country: Turkey
facility: Mugla Sıtkı Kocman University Faculty of Medicine
Study officials:
affiliation: Muğla Sıtkı Koçman University
name: Burak SEZGİN, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.
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 2015 Feb 7.