Evaluating Serum Sestrin in Leiomyoma Patients

Evaluation of Serum Sestrin Levels in Patients With Leiomyoma

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.

Study Overview

• Status: Completed
• Conditions: Uterine Leiomyoma
• Intervention / Treatment: Other: Determination of serum sestrin levels

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 Type: Observational
• Enrollment (Actual): 61

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34371
    • Sisli Hamidiye Etfal Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

30 patients diagnosed with uterine leiomyomas within the above mentioned age group (reproductive ages) are included in the study group. 30 age matched healthy subjects are included in the control group.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study Group; 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.	Other: Determination of serum sestrin levels; Serum sestrin levels will be determined using venous blood samples obtained from the subjects.
Control Group; 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.	Other: Determination of serum sestrin levels; Serum sestrin levels will be determined using venous blood samples obtained from the subjects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluating the role of autophagia in the development of leiomyomas by evaluating the serum sestrin levels.	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.	2 months

Collaborators and Investigators

• Sponsor: Sisli Hamidiye Etfal Training and Research Hospital
• Investigators: Study Director: Pinar Yalcin Bahat, MD, University of Health Sciences Turkey, Istanbul Kanuni Sultan Suleyman Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): April 1, 2021

Study Registration Dates

• First Submitted: March 24, 2021
• First Submitted That Met QC Criteria: March 24, 2021
• First Posted (Actual): March 29, 2021

Study Record Updates

• Last Update Posted (Actual): September 21, 2021
• Last Update Submitted That Met QC Criteria: September 20, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Leiomyoma; Myofibroma
• Other Study ID Numbers: Myomsestrin

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No