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Healthcare Service and Assurance Capacity Enhancement Initiative (National Key Clinical Specialty) — Deafness Gene Therapy Screening Program

Healthcare Service and Assurance Capacity Enhancement Initiative (National Key Clinical Specialty) — Deafness Gene Therapy Screening Program

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500110549
Enrollment
Unknown
Registered
2025-10-15
Start date
2025-10-15
Completion date
Unknown
Last updated
2025-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deafness

Interventions

Observation group:None

Sponsors

Eye & ENT Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 65 Years

Inclusion criteria

Inclusion criteria: 1. Have a clinically confirmed diagnosis of hearing loss (conductive, sensorineural, or mixed deafness) 2. Subjects or their legally authorized representatives voluntarily participate and provide written informed consent using the appropriate version of the consent form 3. Agree to the collection of clinical data and a minimum necessary volume of biospecimens, and consent to undergo genetic testing and necessary familial segregation analysis (subject to additional specific consent)

Exclusion criteria

Exclusion criteria: 1. Individuals with an established non-genetic etiology for their hearing loss, including but not limited to: birth asphyxia, prenatal infection history, neonatal hyperbilirubinemia, viral infections, bacterial meningitis, labyrinthitis, trauma-induced hearing loss, autoimmune inner ear disease, otitis media, hearing loss due to tumors of the internal auditory canal or cerebellopontine angle, ototoxicity from chemotherapeutic agents (e.g., cisplatin), noise-induced hearing loss, and presbycusis 2. Any candidate whom the investigator deems unsuitable for participation in the study (e.g., due to an inability to provide consent or comply with the follow-up schedule)

Design outcomes

Primary

MeasureTime frame
pathogenic/likely pathogenic variants;Phenotype;

Countries

China

Contacts

Public ContactYilai Shu

Eye & ENT Hospital of Fudan University

yilaishu@163.com+86 21 6437 7134

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026