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Status unknownNCT03954288Updated May 21, 2019

The Serum Sclerostin Levels in Cholesteatoma Patients

An observational study in Otitis Media Chronic and Cholesteatoma, sponsored by Abant Izzet Baysal University. Status unknown at 1 site in Turkey. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2019-05-21.

Sponsored by Abant Izzet Baysal University · Observational

The sponsor has not verified this record recently (last verified May 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
75
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Otitis Media Chronic
  • Cholesteatoma

Keywords

  • otitis media chronic
  • cholesteatoma
  • sclerostin
03

In context

Otitis

246 studies on the registry are indexed under Otitis; 21 are open to participants now.

This study's planned enrollment of 75 is below the median of 165 across 63 observational studies indexed under Otitis.

Browse Otitis studies →

Lead sponsor

Abant Izzet Baysal University is the lead sponsor of 242 studies on the registry; 64 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
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.

Inclusion criteria

cholesteatoma chronic otitis media

Exclusion criteria

Exclusion Criteria:

Acute infection Malignancy

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
75 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • chronic otitis media

    patients with chronic otitis media without cholesteatoma

    Diagnostic Test: serum for sclerostin ELISA test

  • cholesteatoma

    patients with chronic otitis media whose cholesteatoma

    Diagnostic Test: serum for sclerostin ELISA test

  • control

    patients scheduled to operation with diagnosis of other causes

    Diagnostic Test: serum for sclerostin ELISA test

Interventions

  • Diagnostic testserum for sclerostin ELISA test

    Blood sample to measure serum sclerostin level

06

What researchers measure

Primary outcomes

  1. change of the levels of sclerostin in cholesteatoma at 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.

    Time frame: 1 month

07

Study locations

1 of 1 sites recruiting
  • Özgür Mehmet Yis
    Bolu, Merkez 14100, Turkey
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03954288
Lead sponsor
Abant Izzet Baysal University
Responsible party
Ozgur Mehmet Yis (Assistant Professor Doctor, Abant Izzet Baysal University) — Principal investigator
First posted
May 17, 2019
Start date
Mar 29, 2019
Primary completion
Feb 15, 2020 (estimated)
Completion
Mar 15, 2020 (estimated)
Last update
May 21, 2019

Study contacts

özgür m yis
Contact
dromyis@mynet.com
05324940572

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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