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The Serum Sclerostin Levels in Cholesteatoma Patients

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ClinicalTrials.gov Identifier: NCT03954288
Recruitment Status : Recruiting
First Posted : May 17, 2019
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Ozgur Mehmet Yis, Abant Izzet Baysal University

Brief Summary:
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.

Condition or disease Intervention/treatment
Otitis Media Chronic Cholesteatoma Diagnostic Test: serum for sclerostin ELISA test

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 75 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: The Serum Sclerostin Levels in Cholesteatoma Patients
Actual Study Start Date : March 29, 2019
Estimated Primary Completion Date : February 15, 2020
Estimated Study Completion Date : March 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

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




Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples Without DNA
serum


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

cholesteatoma chronic otitis media

Exclusion Criteria:

Acute infection Malignancy


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): NCT03954288


Contacts
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Contact: özgür m yis 05324940572 dromyis@mynet.com

Locations
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Turkey
Özgür Mehmet Yis Recruiting
Bolu, Merkez, Turkey, 14100
Contact: özgür m yis    5324940572    dromyis@gmail.com   
Sponsors and Collaborators
Abant Izzet Baysal University

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Responsible Party: Ozgur Mehmet Yis, Assistant Professor Doctor, Abant Izzet Baysal University
ClinicalTrials.gov Identifier: NCT03954288     History of Changes
Other Study ID Numbers: AbantIBU-Biochem-OMY-2
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
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
Keywords provided by Ozgur Mehmet Yis, Abant Izzet Baysal University:
otitis media chronic
cholesteatoma
sclerostin
Additional relevant MeSH terms:
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Otitis
Otitis Media
Cholesteatoma
Ear Diseases
Otorhinolaryngologic Diseases
Keratosis
Skin Diseases