- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00422136
Genetics of Middle Ear Disease
November 10, 2017 updated by: Margaretha L. Casselbrant, University of Pittsburgh
Genetic Epidemiology of Otitis Media
The goal of this study is to identify the genes that contribute to susceptibility to recurrent/persistent middle ear disease.
Five hundred families with at least 2 children who have undergone tympanostomy tube insertion will be enrolled.
A blood sample will be obtained from the children who had tubes and any available parent (at least 1), as well as any siblings without significant histories of middle ear disease.
Study Overview
Status
Completed
Conditions
Detailed Description
Using the twin study approach, the investigators demonstrated that time with middle ear effusion (MEE), number of episodes of MEE and numbers of episodes of acute otitis media (AOM) have a strong genetic component.
The point estimate of heritability of time with MEE was 0.73.
While there is significant evidence that susceptibility to recurrent/persistent OM is largely genetically determined, the specific genes which confer susceptibility are unknown.
The overall research strategy to identify genes underlying OM is to apply a three-stage study design that will allow the investigators to balance cost efficiency with statistical power.
Five hundred evaluable pairs of siblings with a history of tympanostomy tube insertion (affected), their parent(s) and available non-affected full siblings will be recruited.
A blood sample will be obtained from each subject for genotyping.
Study Type
Observational
Enrollment (Actual)
2121
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15224
- ENT Research Center, Children's Hospital of Pittsburgh of UPMC
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Families with 2 or more full sibs who had tympanostomy tubes inserted
Description
Inclusion Criteria:
- families: 2 or more full sibs who had tympanostomy tubes inserted
Exclusion Criteria:
- major congenital malformations
- medical conditions with a predisposition for OM (e.g. cleft palate, Down syndrome, or other craniofacial malformations
- cared for in the Intensive Care Unit as neonate
- been on assisted ventilation
- known sensorineural hearing loss
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Margaretha L Casselbrant, MD, PhD, University of Pittsburgh
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2002
Primary Completion (Actual)
July 1, 2007
Study Completion (Actual)
July 1, 2009
Study Registration Dates
First Submitted
January 12, 2007
First Submitted That Met QC Criteria
January 12, 2007
First Posted (Estimate)
January 15, 2007
Study Record Updates
Last Update Posted (Actual)
November 14, 2017
Last Update Submitted That Met QC Criteria
November 10, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01DC005630 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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