Evaluating Serum Sestrin in Leiomyoma Patients

NCT04819633 | Completed

• 1 other identifier: Myomsestrin
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Uterine Leiomyoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

Determination of serum sestrin levels OTHER

Serum sestrin levels will be determined using venous blood samples obtained from the subjects.

Control Group; Study Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Since uterine leiomyomas are evaluated study will be conducted only with female patients
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead

Study Sites (1)

Sisli Hamidiye Etfal Training and Research Hospital

Istanbul, 34371, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Myofibroma

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Pinar Yalcin Bahat, MD

  University of Health Sciences Turkey, Istanbul Kanuni Sultan Suleyman Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Specialist in Obstetrics and Gynecology

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: March 29, 2021
• Study Start: January 1, 2021
• Primary Completion: March 1, 2021
• Study Completion: April 1, 2021
• Last Updated: September 21, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)