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

Completed

• Conditions: Oral Leukoplakia; Oral Cancer

• Registration Number: NCT06469892
• Lead Sponsor: Beijing Stomatological Hospital, Capital Medical University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2020-06-13
• Primary Completion: 2023-06-30
• Study Completion: 2023-07-30
• Status Verified: 2024-06
• Study First Submitted: 2024-06-14
• Study First Submitted QC: 2024-06-19
• Last Update Submitted: 2024-06-19
• Study First Posted: 2024-06-24
• Last Update Posted: 2024-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 225

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The expression level of miR-185 in salivary exosomes	Baseline, pre-biopsy surgery.	Exosomes were isolated from saliva using ultracentrifugation, and total RNA from the exosomes was extracted using TRIzol reagent. Subsequently, the expression level of miR-185 was detected by RT-qPCR.
The expression level of miR-185 in plasma exosomes	Baseline, pre-biopsy surgery.	Exosomes were isolated from plasma using ultracentrifugation, and total RNA from the exosomes was extracted using TRIzol reagent. Subsequently, the expression level of miR-185 was detected by RT-qPCR.

Trial Locations

Locations (1)

Beijing Stomatological Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China