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Completed

NCT Number: NCT04819633

Evaluating Serum Sestrin in Leiomyoma Patients

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Sisli Hamidiye Etfal Training and Research Hospital

Istanbul, 34371, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Determination of serum sestrin levels

Other

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

Primary outcomes

  1. Evaluating the role of autophagia in the development of leiomyomas by evaluating the serum sestrin levels.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Other

Registry information

Official study title

Evaluation of Serum Sestrin Levels in Patients With Leiomyoma

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 29, 2021
Registry last updated
Sep 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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