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Evaluating Serum Sestrin in Leiomyoma Patients

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ClinicalTrials.gov Identifier: NCT04819633
Recruitment Status : Completed
First Posted : March 29, 2021
Last Update Posted : September 21, 2021
Sponsor:
Information provided by (Responsible Party):
Nura Fitnat Topbas Selcuki, Sisli Hamidiye Etfal Training and Research Hospital

Study Description
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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.

Condition or disease Intervention/treatment
Uterine Leiomyoma 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 Design
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Study Type : Observational
Actual Enrollment : 61 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of Serum Sestrin Levels in Patients With Leiomyoma
Actual Study Start Date : January 1, 2021
Actual Primary Completion Date : March 1, 2021
Actual Study Completion Date : April 1, 2021
Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Since uterine leiomyomas are evaluated study will be conducted only with female patients
Accepts Healthy Volunteers:   Yes
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04819633


Locations
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Turkey
Sisli Hamidiye Etfal Training and Research Hospital
Istanbul, Turkey, 34371
Sponsors and Collaborators
Sisli Hamidiye Etfal Training and Research Hospital
Investigators
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Study Director: Pinar Yalcin Bahat, MD University of Health Sciences Turkey, Istanbul Kanuni Sultan Suleyman Training and Research Hospital
More Information
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Responsible Party: Nura Fitnat Topbas Selcuki, MD, Specialist in Obstetrics and Gynecology, Sisli Hamidiye Etfal Training and Research Hospital
ClinicalTrials.gov Identifier: NCT04819633    
Other Study ID Numbers: Myomsestrin
First Posted: March 29, 2021    Key Record Dates
Last Update Posted: September 21, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases