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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05970445
Other study ID # PS/NSEVA-01
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 15, 2023
Est. completion date August 31, 2023

Study information

Verified date August 2023
Source Chinese PLA General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The presence or absence of SC26A4, whether combined with Mondini malformation, and patient age, are important factors affecting the degree of hearing loss in the Chinese population.


Description:

To summarize the Solute Carrier Family 26 Member 4 (SLC26A4) mutation and clinical phenotypic characteristics of Pendred Syndrome/Nonsyndromic Enlarged Vestibular Aqueduct (PS/NSEVA) patients and provide evidence supporting the clinical diagnosis and genetic counseling of patients with PS/NSEVA. A retrospective cohort study for the Chinese population is needed.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 300
Est. completion date August 31, 2023
Est. primary completion date August 1, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: 1. Patients with Enlarged Vestibular Aqueduct; 2. Patients with hearing loss; 3. Patients with results of SLC26A4 sequencing; Exclusion Criteria: Subjects will be excluded from this study if any of the following are present: 1. Audiometric data is incomplete 2. Incomplete basic information 3. Patients who did not undergo HRCT

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Chinese PLA General Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary SLC26A4 sequencing Extraction from patient clinical information database and secondary use. From each patient included in the study, 3 ml of peripheral blood was collected and the DNA extracted for the diagonosis in the past. through study completion, an average of 0.5 year
Primary High-resolution computed tomography of the temporal bone Extraction from patient clinical information database and secondary use. High-resolution computed tomography of the temporal bone is used to measure the width of the vestibular aqueduct (VA) in the left and right ears to determine whether other inner ear malformations exist. through study completion, an average of 0.5 year
Primary Hearing test Extraction from patient clinical information database and secondary use. The Auditory Steady State Response test is conducted to evaluate the degree of hearing loss. through study completion, an average of 0.5 year
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