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Genetics of Middle Ear Disease

NCT ID: NCT00422136

Last Updated: 2017-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2121 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-07-31

Study Completion Date

2009-07-31

Brief Summary

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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

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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

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Otitis Media

Keywords

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middle ear otitis genetics

Study Design

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Observational Model Type

FAMILY_BASED

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Margaretha L. Casselbrant

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Margaretha L Casselbrant, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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ENT Research Center, Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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Casselbrant ML, Mandel EM, Jung J, Ferrell RE, Tekely K, Szatkiewicz JP, Ray A, Weeks DE. Otitis media: a genome-wide linkage scan with evidence of susceptibility loci within the 17q12 and 10q22.3 regions. BMC Med Genet. 2009 Sep 3;10:85. doi: 10.1186/1471-2350-10-85.

Reference Type RESULT
PMID: 19728873 (View on PubMed)

Other Identifiers

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R01DC005630

Identifier Type: NIH

Identifier Source: secondary_id

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R01DC005630

Identifier Type: NIH

Identifier Source: org_study_id

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