Distribution of Bacteria in OME After Radiotherapy For NPC.

NCT06523933 | Active Not Recruiting

• 1 other identifier: SYSKY-2023-448-01
• Study Type: observational
• Target: 234
• Locations: 1 country
• Sites: 1

Brief Summary

To observe the prognostic difference of tympanocentesis in different kinds of otitis media effusion.

Conditions

Otitis Media Effusion; Nasopharyngeal Carcinoma

Keywords

Otitis Media Effusion; Nasopharyngeal Carcinoma; Bacteria

Outcome Measures

Primary Outcomes (1)

• Positive Bacterial Culture Rate in Middle Ear Effusion

  Up to 24 weeks

Secondary Outcomes (2)

• Changes in Air Pressure (Tympanogram)

  Collected at 6, 12, 24 Weeks after Tympanocentesis

• Eustachian Tube Dysfunction Questionnaire (ETDQ-7)

  Collected at 6, 12, 24 Weeks after Tympanocentesis

Study Arms (4)

ON+

Patients with OME after NPC with a Positive Result of Bacteria Culture of Middle Ear Effusion.

ON-

Patients with OME after NPC with a Negative Result of Bacteria Culture of Middle Ear Effusion.

O+

Patients with OME with a Positive Result of Bacteria Culture of Middle Ear Effusion.

O-

Patients with OME with a Negative Result of Bacteria Culture of Middle Ear Effusion.

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with OME and OME after radiotherapy for NPC, who are given the treatment of tympanostomy only, including outpatient and inpatient patients, were included in the study.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

middle ear effusion

MeSH Terms

Conditions

Otitis Media with Effusion; Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

Otitis Media; Otitis; Ear Diseases; Otorhinolaryngologic Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases

Study Officials

• Hao Xiong

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 26, 2024
• Study Start: May 12, 2024
• Primary Completion: November 12, 2024
• Study Completion: May 12, 2025
• Last Updated: July 26, 2024

Record last verified: 2024-07

Locations

CN (1)