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出境医 / 临床实验 / The Serum Sclerostin Levels in Cholesteatoma Patients

The Serum Sclerostin Levels in Cholesteatoma Patients

Study Description
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.
Study Design
Layout table for study information
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
Arms 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

Outcome Measures
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

Eligibility Criteria
Layout table for eligibility information
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

Contacts and Locations

Contacts
Layout table for location contacts
Contact: özgür m yis 05324940572 dromyis@mynet.com

Locations
Layout table for location information
Turkey
Özgür Mehmet Yis Recruiting
Bolu, Merkez, Turkey, 14100
Contact: özgür m yis    5324940572    dromyis@gmail.com   
Sponsors and Collaborators
Abant Izzet Baysal University
Tracking Information
First Submitted Date April 30, 2019
First Posted Date May 17, 2019
Last Update Posted Date May 21, 2019
Actual Study Start Date March 29, 2019
Estimated Primary Completion Date February 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 17, 2019)
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.
Original Primary Outcome Measures
 (submitted: May 16, 2019)
chande 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. We hope that the results of our study will initiate new processes that can be used in clinical applications.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Serum Sclerostin Levels in Cholesteatoma Patients
Official Title The Serum Sclerostin Levels in Cholesteatoma Patients
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.
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 [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 1 Day
Biospecimen Retention:   Samples Without DNA
Description:
serum
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.
Condition
  • Otitis Media Chronic
  • Cholesteatoma
Intervention Diagnostic Test: serum for sclerostin ELISA test
Blood sample to measure serum sclerostin level
Study Groups/Cohorts
  • chronic otitis media
    patients with chronic otitis media without cholesteatoma
    Intervention: Diagnostic Test: serum for sclerostin ELISA test
  • cholesteatoma
    patients with chronic otitis media whose cholesteatoma
    Intervention: Diagnostic Test: serum for sclerostin ELISA test
  • control
    patients scheduled to operation with diagnosis of other causes
    Intervention: Diagnostic Test: serum for sclerostin ELISA test
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 16, 2019)
75
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 15, 2020
Estimated Primary Completion Date February 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

cholesteatoma chronic otitis media

Exclusion Criteria:

Acute infection Malignancy

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT03954288
Other Study ID Numbers AbantIBU-Biochem-OMY-2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Ozgur Mehmet Yis, Abant Izzet Baysal University
Study Sponsor Abant Izzet Baysal University
Collaborators Not Provided
Investigators Not Provided
PRS Account Abant Izzet Baysal University
Verification Date May 2019

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