Genetics of Middle Ear Disease
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 Design:||Observational Model: Family-Based
Time Perspective: Cross-Sectional
|Official Title:||Genetic Epidemiology of Otitis Media|
Blood samples, DNA
|Study Start Date:||July 2002|
|Study Completion Date:||July 2009|
|Primary Completion Date:||July 2007 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00422136
|United States, Pennsylvania|
|ENT Research Center, Children's Hospital of Pittsburgh of UPMC|
|Pittsburgh, Pennsylvania, United States, 15224|
|Principal Investigator:||Margaretha L Casselbrant, MD, PhD||Children's Hospital of Pittsburgh|