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Changes in oral leukoplakia with diabetes mellitus microenvironment and its effect on the risk of malignant transformation

Changes in oral leukoplakia with diabetes mellitus microenvironment and its effect on the risk of malignant transformation

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500098677
Enrollment
Unknown
Registered
2025-03-12
Start date
2025-03-17
Completion date
Unknown
Last updated
2025-03-17

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

Conditions

oral leukoplakia

Interventions

Oral leukoplakia with diabetes mellitus group:None
Oral leukoplakia without diabetes mellitus group:None
Oral squamous cell carcinoma with diabetes mellitus group:None
Healthy control group with diabete:None
Healthy control group without diabete:None

Sponsors

Peking University School and Hospital of Stomatology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion criteria for the oral leukoplakia and oral squamous cell carcinoma group: 1 Patients with clinical and pathologic diagnosis of oral leukoplakia and oral squamous cell carcinoma; 2 18-75 years old, gender is not limited; 3 Informed and consenting to biopsy with complete information in the pathology report. 4 Patients with oral leukoplakia or oral squamous cell carcinoma with diabetes mellitus, with fasting blood glucose > 8.6 mmol/L or glycated hemoglobin > 7.0%. Patients without DM: no diagnosis of diabetes mellitus and fasting blood glucose 3.9 - 5.5 mmol/L or glycated hemoglobin 4.0%-6.0%; 5 Non-smoker or quit smoking for more than 10 years Healthy control group inclusion criteria: 1 Patients with clinical and pathologic diagnosis of mucous cysts and inflammatory hyperplasia; 2 18-75 years old, gender is not limited; 3 Complete information of pathology report. 4 Non-smoking or quit smoking for more than 10 years

Exclusion criteria

Exclusion criteria: Oral leukoplakia and oral squamous cell carcinoma group exclusion criteria: 1 History of radiation therapy to the head and neck; 2 Tumors other than oral cavity; 3 Pregnancy or lactation and minors; 4 Rapidly progressive systemic disease; 5 History of HIV infection or active hepatitis B or C disease; 6 Patients who are unable to cooperate for any reason. 7 History of betel nut chewing. Exclusion criteria for healthy controls: 1 History of head and neck radiation therapy; 2 Tumors other than those of the mouth and tongue; 3 Pregnancy or lactation and minors; 4 Rapidly progressive disease; 5 History of HIV infection or active hepatitis B or C disease; 6 Patients who are unable to cooperate for any reason; 7 History of betel nut chewing; 8 Presence of other oral mucosal disease in the mouth.

Design outcomes

Primary

MeasureTime frame
Proportion of different cell types;Differently expressed genes;

Countries

China

Contacts

Public ContactHong Hua

Peking University School and Hospital of Stomatology

Honghua1968@aliyun.com+86 10 8219 5349

Outcome results

None listed

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