CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 225 enrolled
Drug / intervention
Detect the expression level of miR-185 in salivary and plasma exosomes.other
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06469892
NCT06469892N/ACompleted

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

Beijing Stomatological Hospital, Capital Medical University·observational·Posted Jun 24, 2024·Updated Jun 24, 2024

In Brief

An observational study evaluating Detect the expression level of miR-185 in salivary and plasma exosomes. for Oral Leukoplakia and Oral Cancer. Completed, enrolled 225 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJun 24, 2024
Enrollment StartJun 13, 2020
Primary CompletionJun 30, 2023
Study CompletionJul 30, 2023
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 2.0 years ago

Interventions

Detect the expression level of miR-185 in salivary and plasma exosomes.other

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.