NCT00422136

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,121

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2002

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 15, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

November 14, 2017

Status Verified

November 1, 2017

Enrollment Period

5 years

First QC Date

January 12, 2007

Last Update Submit

November 10, 2017

Conditions

Otitis Media

Keywords

middle earotitisgenetics

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Families with 2 or more full sibs who had tympanostomy tubes inserted

You may qualify if:

  • families: 2 or more full sibs who had tympanostomy tubes inserted

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Pittsburgh, Pennsylvania, 15224, United States

Location

Related Publications (1)

  • 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.

    PMID: 19728873RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples, DNA

MeSH Terms

Conditions

Otitis MediaOtitis

Condition Hierarchy (Ancestors)

Ear DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Margaretha L Casselbrant, MD, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 12, 2007

First Posted

January 15, 2007

Study Start

July 1, 2002

Primary Completion

July 1, 2007

Study Completion

July 1, 2009

Last Updated

November 14, 2017

Record last verified: 2017-11

Locations

US(1)