The Serum Sclerostin Levels in Cholesteatoma Patients

NCT ID: NCT03954288

Last Updated: 2019-05-21

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

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Recruitment Status

UNKNOWN

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-29

Study Completion Date

2020-03-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Otitis Media Chronic Cholesteatoma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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chronic otitis media

patients with chronic otitis media without cholesteatoma

serum for sclerostin ELISA test

Intervention Type DIAGNOSTIC_TEST

Blood sample to measure serum sclerostin level

cholesteatoma

patients with chronic otitis media whose cholesteatoma

serum for sclerostin ELISA test

Intervention Type DIAGNOSTIC_TEST

Blood sample to measure serum sclerostin level

control

patients scheduled to operation with diagnosis of other causes

serum for sclerostin ELISA test

Intervention Type DIAGNOSTIC_TEST

Blood sample to measure serum sclerostin level

Interventions

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serum for sclerostin ELISA test

Blood sample to measure serum sclerostin level

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

cholesteatoma chronic otitis media

Exclusion Criteria

Acute infection Malignancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abant Izzet Baysal University

OTHER

Sponsor Role lead

Responsible Party

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Ozgur Mehmet Yis

Assistant Professor Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Özgür Mehmet Yis

Bolu, Merkez, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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özgür m yis

Role: CONTACT

05324940572

Facility Contacts

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özgür m yis

Role: primary

5324940572

Other Identifiers

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AbantIBU-Biochem-OMY-2

Identifier Type: -

Identifier Source: org_study_id

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