NCT06469892

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

Application of Salivary and Plasma Exosomes in the Diagnosis of Oral Leukoplakia Malignant Transformation and Prognosis Monitoring of Oral Cancer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 225 (actual)
• Sponsor: Beijing Stomatological Hospital, Capital Medical University · Academic / Other
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Oral Leukoplakia
• Oral Cancer

Interventions

Type	Name	Description
OTHER	Detect the expression level of miR-185 in salivary and plasma exosomes.	Participants were instructed to refrain from eating, drinking, brushing their teeth, rinsing their mouth, or taking medications for one hour before saliva collection. They were then asked to bend over, lower their head, open their mouth, and allow saliva to flow naturally without chewing or spitting. Using a specialized container, 2 mL of unstimulated saliva was collected. Participants fasted overnight before blood collection. Researchers used plasma tubes containing anticoagulant (EDTA) to obtain venous blood (4-5 mL) from the participants\' upper arm. Subsequently, the blood was gently inverted to ensure optimal contact with the anticoagulant before centrifugation at 2000 rpm and 4°C for 10 minutes. Following centrifugation, the supernatant was extracted.

Timeline

• Start date: 2020-06-13
• Primary completion: 2023-06-30
• Completion: 2023-07-30
• First posted: 2024-06-24
• Last updated: 2024-06-24

Locations

1 site across 1 country: China