NCT03954288

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 29, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 30, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 17, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2020

Completed
Last Updated

May 21, 2019

Status Verified

May 1, 2019

Enrollment Period

11 months

First QC Date

April 30, 2019

Last Update Submit

May 17, 2019

Conditions

Keywords

otitis media chroniccholesteatomasclerostin

Outcome Measures

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.

    1 month

Study Arms (3)

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

Blood sample to measure serum sclerostin level

cholesteatomachronic otitis mediacontrol

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • cholesteatoma chronic otitis media

You may not qualify if:

  • Acute infection Malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Özgür Mehmet Yis

Bolu, Merkez, 14100, Turkey (Türkiye)

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

CholesteatomaSclerosteosis

Condition Hierarchy (Ancestors)

KeratosisSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

özgür m yis

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Doctor

Study Record Dates

First Submitted

April 30, 2019

First Posted

May 17, 2019

Study Start

March 29, 2019

Primary Completion

February 15, 2020

Study Completion

March 15, 2020

Last Updated

May 21, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations