Condition or disease | Intervention/treatment |
---|---|
Otitis Media Chronic Cholesteatoma | Diagnostic Test: serum for sclerostin ELISA test |
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 |
Group/Cohort | Intervention/treatment |
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chronic otitis media
patients with chronic otitis media without cholesteatoma
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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
|
Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
cholesteatoma chronic otitis media
Exclusion Criteria:
Acute infection Malignancy
Contact: özgür m yis | 05324940572 | dromyis@mynet.com |
Turkey | |
Özgür Mehmet Yis | Recruiting |
Bolu, Merkez, Turkey, 14100 | |
Contact: özgür m yis 5324940572 dromyis@gmail.com |
Tracking Information | |||||
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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 |
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.
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Original Primary Outcome Measures |
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.
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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 |
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Target Follow-Up Duration | 1 Day | ||||
Biospecimen | Retention: Samples Without DNA Description:
serum
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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 |
|
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Intervention | Diagnostic Test: serum for sclerostin ELISA test
Blood sample to measure serum sclerostin level
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Study Groups/Cohorts |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Unknown status | ||||
Estimated Enrollment |
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 |
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Sex/Gender |
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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 |
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IPD Sharing Statement |
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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 |