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Developing and Optimizing an Exosome-Based Model for Diagnosing Malignant Transformation and Predicting Risk in Oral Leukoplakia Using Machine Learning and Neural Networks

Developing and Optimizing an Exosome-Based Model for Diagnosing Malignant Transformation and Predicting Risk in Oral Leukoplakia Using Machine Learning and Neural Networks

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600119030
Enrollment
Unknown
Registered
2026-02-14
Start date
2024-10-29
Completion date
Unknown
Last updated
2026-02-16

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

Conditions

Oral leukoplakia

Interventions

Study 2: Oral Leukoplakia Malignant Transformation Prediction Group:NA
Study 3: Model Group for Identifying Abnormal Proliferation and Malignant Transformation in Oral Leukoplakia:NA
Study 4: Intelligent Management System for Oral Leukoplakia Patients: Control Group:NA
Study 4: Intervention Group of the Intelligent Management System for Oral Leukoplakia Patients:Intelligent Management System for Oral Leukoplakia Patients

Sponsors

Beijing Stomatological Hospital , Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Study 2 Inclusion Criteria: (1) Age 18–80 years, no gender restrictions; (2) Previously participated in the research project "Application of Salivary and Serum Exosomes in Diagnosing Malignant Transformation of Oral Leukoplakia and Monitoring Prognosis of Oral Cancer."; 2.Study 3 Inclusion Criteria: (1) Age 18–80 years, no gender restrictions; (2) Clinically diagnosed with oral leukoplakia; (3) Histopathologically diagnosed with oral leukoplakia or leukoplakia with malignant potential; (4) Photographs of lesions taken prior to pathological biopsy. 3.Study 4 Inclusion Criteria: (1) Age 18–80 years, no gender restrictions; (2) Clinical and pathological diagnosis consistent with oral leukoplakia.

Exclusion criteria

Exclusion criteria: 1.Study 2 Exclusion Criteria: (1) Pregnant or lactating women; (2) Individuals with mental disorders or intellectual disabilities. 2.Study 3 Exclusion Criteria: None. 3.Study 4 Exclusion Criteria: (1) Pregnant or lactating women; (2) Individuals with severe systemic chronic diseases (cardiovascular, hepatic, pulmonary, renal, endocrine) or malignancies; (3) Individuals with severe psychiatric disorders or intellectual disabilities.

Design outcomes

Primary

MeasureTime frame
Study 2 Measurement Indicator: Whether OLK Lesions Have Become Malignant;Study 3 Measurement Indicators: Histopathological Findings in OLK Patients;Study 4: Key Measurement Indicators for Determining Whether OLK Lesions Have Become Malignant;—

Countries

China

Contacts

Public ContactXiaobing Guan

Beijing Stomatological Hospital , Capital Medical University

guanxbing2013@qq.com+86 10 57099246

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026