Evaluating Serum Sestrin in Leiomyoma Patients

Completed

• Conditions: Uterine Leiomyoma
• Interventions: Other: Determination of serum sestrin levels

• Registration Number: NCT04819633
• Lead Sponsor: Sisli Hamidiye Etfal Training and Research Hospital

Brief Summary

Leiomyomas are the most common benign neoplasms of women's reproductive system affecting 20-30% of women within the reproductive ages. Sestrins are serum proteins which are highly expressed under circumstances of DNA damage, hypoxia and oxditive stress and play an important role in autophagia. The aim of this study is to evaluate the relationship of serum sestrin proteins with development of leiomyomas.

Detailed Description

Leiomyomas are the benign neoplasms of uterus and the role of genetics, estrogen levels and obesity has already been shown in their development. Higher levels of serum sestrin proteins have already been associated with DNA damage, hypoxia and oxidative stress and sestrin plays an important role in autophagia. In order to evaluate the role of serum sestrin in the development of leiomyomas 30 patients between 18-45 years of age who were diagnosed with uterine leiomyomas with transvaginal ultrasonography will be included in the study group. Their serum sestrin levels will be determined and compared with that of 30 healthy subjects recruited during the same study period at the same clinic.

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2021-03-01
• Study First Submitted: 2021-03-24
• Study First Submitted QC: 2021-03-24
• Study First Posted: 2021-03-29
• Study Completion: 2021-04-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-20
• Last Update Posted: 2021-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 61

Inclusion Criteria

• 18-45 years of age
• patients diagnosed with uterine leiomyomas will be included in the study group
• patients without any additional comorbidities
• patients without any autoimmune diseases

Exclusion Criteria

• patients with systemic diseases
• patients with known chronic inflammatory diseases
• patients using hormonal and/or medical therapy
• pregnant women
• lactating women
• patients with malignant diseases

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study Group	Determination of serum sestrin levels	30 patients within the reproductive ages (18-45 years) who were diagnosed with leiomyomas using transvaginal ultrasonography without any additional chronic, systemic or autoimmune disease, are not currently using any medical, hormonal, antiinflammatory treatments are included in this group.
Control Group	Determination of serum sestrin levels	30 healthy subjects within the reproductive ages (18-45 years) who visited the outpatient gynecological clinic for routine examination who do not have any additional chronic, systemic or autoimmune disease, who are not currently using any medical, hormonal, antiinflammatory treatments are included in this group.

Primary Outcome Measures

Name	Time	Method
Evaluating the role of autophagia in the development of leiomyomas by evaluating the serum sestrin levels.	2 months	Increased levels of serum sestrin proteins are associated with impaired autophagia. This association will be evaluated in the context of leiomyoma patients by measuring serum sestrin levels in blood samples obtained from these patients and comparing them with the sestrin levels measured in healthy subjects.

Trial Locations

Locations (1)

Sisli Hamidiye Etfal Training and Research Hospital; 🇹🇷 Istanbul, Turkey