Distribution of Bacteria in OME After Radiotherapy For NPC. (NCT06523933) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Distribution of Bacteria in OME After Radiotherapy For NPC.
China234 participantsStarted 2024-05-12
Plain-language summary
To observe the prognostic difference of tympanocentesis in different kinds of otitis media effusion.
Who can participate
Age range
15 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* patients clinical diagnosis of OME or OME after radiotherapy for NPC (Diagnostic criteria: fluid visible in the middle ear and a type B tympanogram).
* patients volunteered to participate in the study and signed the informed consent
Exclusion Criteria:
* NPC recurrence or other malignant tumor after radiotherapy.
* clear diagnosis of Eustachian ostium atresia or nasal obstruction diseases, such as severe deviated nasal septum, choanal atresia, osteoradionecrosis of skull base after radiotherapy, etc.
* pregnant and lactating women.
* patients with severe underlying diseases or with severe liver and kidney dysfunction.
* patients who could not cooperate (including poor hearing and radiation encephalopathy)
* patients with other middle ear diseases, such as middle ear cholesteatoma, osteoradionecrosis of temporal bone after radiotherapy, etc.
* severe deglutition disorders
* cleft palate
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Positive Bacterial Culture Rate in Middle Ear Effusion
Timeframe: Up to 24 weeks
Trial details
NCT IDNCT06523933
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University