The Serum Sclerostin Levels in Cholesteatoma Patients

May 17, 2019 updated by: Ozgur Mehmet Yis, Abant Izzet Baysal University
The aim of this study is to investigate the levels of sclerostin in patients with cholesteatoma. So far, there is no study showing the levels of sclerostin in cholesteatoma. The investigators hope that the results of our study will start new processes that can be used in the clinic.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Chronic otitis media (COM) is the perforation of the eardrum and mucosal inflammation of the space in the middle ear and the air cavities of the temporal bone over a period of three months. Although COM is defined as a multifactorial disease, its etiopathogenesis has not been fully elucidated. Cholesteatoma is a condition that disrupts the balance between bone formation and resorption in COM. The cholesteatoma is a destructive squamous epithelial lesion of temporal bone, it gradually expands and leads to serious complications by the destruction of near bone structures, ossicular chain and otic capsule. A growing debate examines the role of bone formation and destruction with osteoblasts, osteocytes and osteoclast cells in cholesteatoma formation. Sclerostin is a glycoprotein that plays a role in the regulation of bone metabolism secreted by osteocytes. Antibodies directed against sclerostin stimulate bone formation and represent a new therapeutic option for the treatment of increased bone resorption diseases, such as osteoporosis and generalized bone loss, inflammatory diseases with cartilage damage. The aim of this study is to investigate the levels of sclerostin in patients with cholesteatoma. So far, there is no study showing the levels of sclerostin in cholesteatoma. The investigators hope that the results of our study will start new processes that can be used in the clinic.

Study Type

Observational

Enrollment (Anticipated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Merkez
      • Bolu, Merkez, Turkey, 14100
        • Recruiting
        • Özgür Mehmet Yis
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The experimental group of this study consisted of 75 patients who applied to AIBU Bolu Izzet Baysal Training and Research Hospital Ear Nose Throat Clinic and regularly followed up. A control group of approximately 50 people, which is demographically similar, and patients whose scheduled for operation with other causes.

Description

Inclusion Criteria:

cholesteatoma chronic otitis media

Exclusion Criteria:

Acute infection Malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
chronic otitis media
patients with chronic otitis media without cholesteatoma
Diagnostic test: serum for sclerostin ELISA test
Blood sample to measure serum sclerostin level
cholesteatoma
patients with chronic otitis media whose cholesteatoma
Diagnostic test: serum for sclerostin ELISA test
Blood sample to measure serum sclerostin level
control
patients scheduled to operation with diagnosis of other causes
Diagnostic test: serum for sclerostin ELISA test
Blood sample to measure serum sclerostin level

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of the levels of sclerostin in cholesteatoma at 1 month
Time Frame: 1 month
So far, there is no study showing the levels of sclerostin in cholesteatoma. The investigators hope that the results of our study will initiate new processes that can be used in clinical applications.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abant Izzet Baysal University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 29, 2019

Primary Completion (ANTICIPATED)

February 15, 2020

Study Completion (ANTICIPATED)

March 15, 2020

Study Registration Dates

First Submitted

April 30, 2019

First Submitted That Met QC Criteria

May 16, 2019

First Posted (ACTUAL)

May 17, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 21, 2019

Last Update Submitted That Met QC Criteria

May 17, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AbantIBU-Biochem-OMY-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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