Clinical Trials Directory

Trials / Completed

CompletedNCT00422136

Genetics of Middle Ear Disease

Genetic Epidemiology of Otitis Media

Status
Completed
Phase
Study type
Observational
Enrollment
2,121 (actual)
Sponsor
University of Pittsburgh · Academic / Other
Sex
All
Age
Healthy volunteers
Accepted

Summary

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.

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.

Conditions

Timeline

Start date
2002-07-01
Primary completion
2007-07-01
Completion
2009-07-01
First posted
2007-01-15
Last updated
2017-11-14

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00422136. Inclusion in this directory is not an endorsement.