Evaluating Serum Sestrin in Leiomyoma Patients

NCT ID: NCT04819633

Last Updated: 2021-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

61 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2021-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Uterine Leiomyoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Determination of serum sestrin levels

Intervention Type OTHER

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.

Determination of serum sestrin levels

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Determination of serum sestrin levels

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sisli Hamidiye Etfal Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nura Fitnat Topbas Selcuki

MD, Specialist in Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pinar Yalcin Bahat, MD

Role: STUDY_DIRECTOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sisli Hamidiye Etfal Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Myomsestrin

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Open Label Immunotherapy of Myoma
NCT03550703 UNKNOWN PHASE2
A Comprehensive, Multinational GIST Registry
NCT07273045 NOT_YET_RECRUITING