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Construction and validation of a AI-driven multi-gene methylation-based risk assessment model for oral carcinogenesis

Construction and validation of a AI-driven multi-gene methylation-based risk assessment model for oral carcinogenesis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500112756
Enrollment
Unknown
Registered
2025-11-19
Start date
2025-08-29
Completion date
Unknown
Last updated
2025-11-24

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

Conditions

Oral potentially malignant disorders (with or without epithelial dysplasia) including oral leukoplakia, oral erythroplakia, oral lichen planus, oral submucosal fibrosis

Interventions

Index test:AI-Driven Multi-Gene Methylation Risk Assessment Model for Oral Mucosal Carcinogenesis

Sponsors

Hospital of Stomatology, Wuhan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients clinically diagnosed with oral leukoplakia, oral erythroplakia, oral lichen planus, oral submucous fibrosis, or other potentially malignant oral disorders, as well as patients with suspected oral cancer, from whom extra normal oral mucosa can be obtained during wisdom tooth extraction or reconstructive surgery; 2. Willing to undergo histopathological examination, with pathology showing any of the five categories: normal oral mucosa, simple epithelial hyperplasia, mild epithelial dysplasia, moderate-to-severe epithelial dysplasia, or oral squamous cell carcinoma; 3. Understand the project and provide informed consent by signing the consent form.

Exclusion criteria

Exclusion criteria: 1.Patients with coagulation disorders.

Design outcomes

Primary

MeasureTime frame
Area under receiver operating characteristic curve (AUC);Sensitivity;Specificity;

Secondary

MeasureTime frame
The number of detected genes for constructing the model;

Countries

China

Contacts

Public ContactLu Rui

Hospital of Stomatology, Wuhan University

lurui@whu.edu.cn+86 27 87686213

Outcome results

None listed

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