Saliva and Plasma Exosomes for Oral Leukoplakia Malignant Transformation Diagnosis and Oral Cancer Prognosis Monitoring

Beijing Stomatological Hospital, Capital Medical University

Status: Completed

Conditions: Oral Cancer; Oral Leukoplakia

Treatments: Other: Detect the expression level of miR-185 in salivary and plasma exosomes.

Study type: Observational

Funder types: Other

Identifiers

NCT06469892

CMUSH-IRB-KJ-PJ-2020-10

Z191100006619042 (Other Grant/Funding Number)

Details and patient eligibility

About

The goal of this observational study is to test the expression levels of salivary and plasma exosomal miR-185 in patients with oral leukoplakia and oral squamous cell carcinoma. The main questions it aims to answer are:

• Is it possible to identify the cancer risk of oral leukoplakia in its early stages by detecting salivary and plasma exosomal miR-185?
• Is it possible to monitor the cancer risk of oral leukoplakia and the prognosis of oral cancer using salivary exosomal miR-185?

Participants will be asked to:

• Cooperate with the investigators in completing the oral examination.
• Take saliva and plasma before the biopsy surgery.
• Perform the biopsy surgery following the usual diagnostic procedures.
• Attend regular follow-up appointments (every 3 months) for the duration of the study.

Full description

The first part of the study is a cross-sectional study in which the investigators will detect the expression level of salivary exosomal miR-185 in the participants at a single time point. The second part of the study is a prospective cohort study, in which the investigators will conduct regular follow-ups on the participants enrolled in the first part.

Enrollment: 225 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males or females aged 30~80 years.
• Clinical diagnosis consistent with oral leukoplakia and oral cancer.
• Individuals with local stimulating factors correlated with oral lesions (including residual roots, residual crowns, poor oral restorations, cheek biting, and tongue biting habits).
• Oral lesions not subjected to any treatment, including laser, photodynamic therapy, radiotherapy, and chemotherapy.

Exclusion criteria

• Pathological diagnosis of another disease rather than oral leukoplakia or squamous cell carcinoma.
• Females who were pregnant or breastfeeding.
• Individuals who had malignancy, severe and precariously controlled diabetes mellitus, episodes of cardiovascular disease, hepatic or renal dysfunction, respiratory disease, hematologic disease, or immune abnormalities in the past year.
• Individuals with a psychiatric disorder.
• Other conditions deemed inappropriate for study participation by the researchers.