Otitis Media With EffusionMMP and OMENCT03611842
Study of the Expression of MMPs in OME in Children With Atrophy of the Eardrum
An observational study of Otitis Media With Effusion, run by University Hospital, Montpellier at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 12 years
- Conditions the study is for
- Otitis Media With Effusion
- What is being tested?
- preservation of mucosal otitis media
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 30 Sep 2018to 30 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Children under the age of twelve with OME and surgical indication for myringostomy of tube placement
Who may be able to join
- every children under 12 yo operated on in Gui de Chauliac Hospital
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Expression of MMPs (Metalloproteinase Matricial) in OME (Otitis Media With Effusion) in Children Under Twelve Years Old With Atrophy of the Eardrum
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.
Read the detailed 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.
- Conditions
- Otitis Media With Effusion
- Being tested
- preservation of mucosal otitis media
- Medical subject headings
- Otitis Media with Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preservation of mucosal otitis mediaOther
Suction of the middle ear fluid and conservation of the fluid to be collected instead of thrown away into children Healthy eardrum and Atrophic eardrum
| Study group | Role | What they receive |
|---|---|---|
| Healthy eardrum | OME (otitis media with effusion)with normal tympanic membrane Receives: Other: preservation of mucosal otitis media | |
| Atrophic eardrum | OME (otitis media with effusion) with atrophic membrane : thinning of the membrane, retraction pocket Receives: Other: preservation of mucosal otitis media |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microscopic evaluation of the quality of the eardrum : normal or atrophic
Microscopic evaluation of the quality of the eardrum : normal or atrophic
Measured: before surgery
Secondary outcomes (2)
biochemical assay of the level of TIMP
biochemical assay of the level of TIMP
Measured: 1 day
biochemical assay of the level of MMPs
biochemical assay of the level of MMPs
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start30 Sep 2018
- Primary completion1 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otitis Media With EffusionStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- INM : institut des neurosciences Montpellier
- Responsible party
- Sponsor
- Investigators
- Lylou Casteil Baume, ENT resident, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03611842
- Sponsor's protocol ID
- RECHMPL18_0306
- Acronym
- MMP and OME
- Status last verified
- Jul 2018
- First submitted
- 27 Jul 2018
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Expression of MMPs (Metalloproteinase Matricial) in OME (Otitis Media With Effusion) in Children Under Twelve Years Old With Atrophy of the Eardrum
- ClinicalTrials.gov ID
- NCT03611842
- Acronym / sponsor ID
- MMP and OME / RECHMPL18_0306
- Conditions
- Otitis Media With Effusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- INM : institut des neurosciences Montpellier
- Study start
- 30 Sep 2018 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 2 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy eardrum | – | Other: preservation of mucosal otitis mediaOME (otitis media with effusion)with normal tympanic membrane |
| Atrophic eardrum | – | Other: preservation of mucosal otitis mediaOME (otitis media with effusion) with atrophic membrane : thinning of the membrane, retraction pocket |
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children under the age of twelve with OME and surgical indication for myringostomy of tube placement
Key inclusion criteria (1 listed)
- every children under 12 yo operated on in Gui de Chauliac Hospital
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| preservation of mucosal otitis mediaSuction of the middle ear fluid and conservation of the fluid to be collected instead of thrown away into children Healthy eardrum and Atrophic eardrum | Other | Atrophic eardrum, Healthy eardrum |
Primary outcome
Microscopic evaluation of the quality of the eardrum : normal or atrophic
Time frame: before surgery
Microscopic evaluation of the quality of the eardrum : normal or atrophic
2 secondary outcomes
biochemical assay of the level of TIMP
Time frame: 1 day
biochemical assay of the level of MMPs
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lylou Casteil Baume, ENT resident principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Otitis Media With Effusion, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microscopic evaluation of the quality of the eardrum : normal or atrophic (time frame: before surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2019.