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A Multicenter Clinical Study on the Application of a Non-invasive Intelligent Risk Prediction Model for OPMDs

A Multicenter Clinical Study on the Application of a Non-invasive Intelligent Risk Prediction Model for OPMDs

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600122273
Enrollment
Unknown
Registered
2026-04-10
Start date
2025-07-10
Completion date
Unknown
Last updated
2026-04-14

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

Conditions

Potential malignant lesion of the oral mucosa

Interventions

Gold Standard:Histopathological examination of biopsy specimens will serve as the gold/reference standard. All enrolled cases will undergo biopsy, and pathological grading will be determined according
Index test:The index tests are noninvasive oral exfoliative cell-based assessments, including liquid-based cytology (LBC), DNA ploidy analysis, and DNA methylation testing (ZNF582 and SHOX2), and a tr

Sponsors

Hospital of Stomatology, SunYat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Clinical and pathological diagnosis of oral erythema, oral leukoplakia, oral lichen planus, oral submucosal fibrosis, and other potential malignant lesions in the oral cavity with mild, moderate, and severe abnormal hyperplasia of mucosal epithelium, as well as patients with squamous cell carcinoma; 2.Not treated with hormones, lasers, radiation, or chemical drugs; 3.People who can sign informed consent forms;

Exclusion criteria

Exclusion criteria: 1.Unable to meet follow-up requirements; 2.Massive missing or incomplete data;

Design outcomes

Primary

MeasureTime frame
The model's ability to distinguish;

Secondary

MeasureTime frame
The consistency and calibration performance of the prediction model;

Countries

China

Contacts

Public ContactJuan Xia

Hospital of Stomatology, SunYat-sen University

xiajuan@mail.sysu.edu.cn+86 20 8387 0405

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026