Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05402267 |
| Other study ID # |
OME-2022 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2022 |
| Est. completion date |
May 1, 2024 |
Study information
| Verified date |
May 2022 |
| Source |
Eye & ENT Hospital of Fudan University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The particularity of adenoids, as a reservoir of bacterial pathogens and immune molecules, is
known to be significantly involved in children with otitis media with effusion (OME). As an
important carrier of intercellular substance transfer and signal transduction, exosomes with
different biological functions can be secreted by different types of cells. There remains
significant uncertainty regarding the clinical transmitter of exosomes to OME, especially in
its pathophysiologic development. In this study, the investigators try to elucidate the
biological functions of exosomes in children with adenoid hypertrophy accompanied by OME.
Patients with adenoid hypertrophy or otitis media will be separated into three groups: those
with adenoid hypertrophy, with otitis media and with adenoid hypertrophy and otitis media
both, as well as a healthy control group. Participants in the four groups will have their
middle ear effusion, nasopharyngeal secretion, and peripheral blood samples taken, from which
exosomes will be separated for further analysis. Adenoidectomy will be conducted in adenoid
hypertrophy accompanied by OME and adenoid hypertrophy alone and their adenoid tissue will be
collected. Blood will be collected again 3 months after surgery and middle ear and
nasopharyngeal examinations will be performed. Exosomes will be isolated for follow-up
studies as before surgery. Investigators will also use proteome research, exosome biomarkers,
and high-throughput sequencing to examine the pathophysiology of OME, particularly
inflammation-related etiology, in order to provide novel ideas for OME diagnosis and
treatment.
Description:
This study will explore the pathogenesis of OME by detecting the exosome in middle ear fluid,
nasopharyngeal secretions and peripheral blood in order to identify areas of opportunity for
future research and to provide a theoretical basis for drug development for the treatment of
secretory otitis media.
240 subjects will be recruited from Eye and ENT hospital of Fudan University or the
community. They will be divided into four groups: adenoid hypertrophy accompanied by OME
(group OA, n=60), adenoid hypertrophy alone (group CA, n=60), OME alone (group CO, n=60) and
healthy control group (children without OME or adenoid hypertrophy, n=60). All participants
will undergo the examinations of middle ear and nasopharynx in addition to blood collection
when they get into the groups. The exosomes will be isolated form middle ear effusions,
nasopharyngeal secretions/adenoid tissue, and peripheral blood collected from all
participants. The OA and CA groups will undergo adenoidectomy and their adenoid tissue will
be collected. Blood will be collected again 3 months after surgery and middle ear and
nasopharyngeal examinations will be performed. Exosomes will be isolated for follow-up
studies as before surgery.
The primary outcome measures will be (1) ANOVA of the alterations and related gene expression
of exosome contents in nasopharyngeal secretions in the four groups; (2) microbial
alterations and the exosomes from biofilm on the surface of the adenoids in OA and CA groups
preoperative and postoperative; and (3) the differences of exosomes from peripheral blood
samples in OA and CA groups preoperative and postoperative.
