CompletedNot Applicable

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

China225 participantsStarted 2020-06-13

Plain-language summary

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.

Who can participate

Age range30 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

The expression level of miR-185 in salivary exosomes

Timeframe: Baseline, pre-biopsy surgery.

The expression level of miR-185 in plasma exosomes

Timeframe: Baseline, pre-biopsy surgery.

Trial details

NCT IDNCT06469892

SponsorBeijing Stomatological Hospital, Capital Medical University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-06-30