Evaluating Serum Sestrin in Leiomyoma Patients

Uterine Leiomyoma Clinical Trial

Official title:

Evaluation of Serum Sestrin Levels in Patients With Leiomyoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04819633
• Other study ID #: Myomsestrin
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: April 1, 2021

Study information

• Verified date: September 2021
• Source: Sisli Hamidiye Etfal Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: April 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Leiomyoma

Intervention

Other:
• Determination of serum sestrin levels
Serum sestrin levels will be determined using venous blood samples obtained from the subjects.

Locations

Country	Name	City	State
Turkey	Sisli Hamidiye Etfal Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sisli Hamidiye Etfal Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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