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Study of the Expression of MMPs in OME in Children With Atrophy of the Eardrum (MMP and OME)

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status

Completed

Conditions

Otitis Media With Effusion

Treatments

Other: preservation of mucosal otitis media

Study type

Observational

Funder types

Other

Identifiers

NCT03611842
RECHMPL18_0306

Details and patient eligibility

About

Metalloproteinases (MMPs) constitute a family of endopeptidases that cleaves the extracellular matrix as collagen included in the eardrum. Activity of MMP has been shown in some otitis media with effusion (OME) fluids. These enzymes could be directly linked to the prosnostic of OME as it may damage the eardrum and leads to tympanic atrophy.

The main goal of the study is to find out the correlation between activity of MMPs and tympanic atrophy. The investigator will also study if there is any clinical predictive factors in relation to the level of MMPs.

Full description

The investigator will include 35 children under 12 years old with OME and who need tympanostomy or tube placement under general anesthesia. Middle ear effusion will be collected, divided in two and frozen.

The investigator will perform ELISA tests to measure the level of MMP2 MMP9 MMP7 et TIMP2 (inhibitor of MMPs). The investigator want to compare the level of MMPs between healthy eardrum and atrophic membrane.

Clinical data will be collected such as age, gender, chronicity of the OME, quality of the eardrum and middle ear effusion type to see if there is any difference when MMPs level is higher.

Enrollment

35 patients

Sex

All

Ages

Under 12 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • every children under 12 yo operated on in Gui de Chauliac Hospital

Exclusion criteria

  • when effusion is not possible to collect (too thick or amount of fluid not enough)

Collection of both MEE on each ear when OME is bilateral. We will perform the tests on only one ear. The other one will be kept in case of technical issue. A random draw will establish which ear will be tested.

Trial design

35 participants in 2 patient groups

Healthy eardrum
Description:
OME (otitis media with effusion)with normal tympanic membrane
Treatment:
Other: preservation of mucosal otitis media
Atrophic eardrum
Description:
OME (otitis media with effusion) with atrophic membrane : thinning of the membrane, retraction pocket
Treatment:
Other: preservation of mucosal otitis media

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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