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Construction and validation of multi gene detection kit for head and neck characteristic tumors

Construction and validation of multi gene detection kit for head and neck characteristic tumors

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500106447
Enrollment
Unknown
Registered
2025-07-24
Start date
2025-07-31
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Salivary gland tumors and odontogenic tumors

Interventions

Gold Standard:Gold standard for fusion genes: Using FISH test results as the gold standard
Gold standard for gene mutations: Using Sanger sequencing results as the gold standard.
Index test:Next-generation sequencing (NGS)-based multi-gene detection kits, designed for fusion gene detection in salivary gland tumors, mutation gene detection in salivary gland tumors, and mutation

Sponsors

Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 90 Years

Inclusion criteria

Inclusion criteria: 1. Both male and female patients; 2. Age range: 0 =1cm, with sufficient residual tumor samples remaining after routine pathological diagnosis to simultaneously conduct two sets of tests (single-gene testing and panel multi-gene kit testing); 5. Tumor component in sections should exceed 50%.

Exclusion criteria

Exclusion criteria: 1. Tumor necrosis exceeds 30% in the slice; 2. Puncture specimen; 3. Poor quality of extracted DNA/RNA (concentration <10ng/ul and OD value 260/280 <1.8); 4. Library construction failure.

Design outcomes

Primary

MeasureTime frame
Sensitivity;Specificity;Area Under ROC Curve;

Countries

China

Contacts

Public ContactJiang Li

Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine

lijiang182000@126.com+86 21 23271699

Outcome results

None listed

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