---
title: Saliva and Plasma Exosomes for Oral Leukoplakia Malignant Transformation Diagnosis and Oral Cancer Prognosis Monitoring
nct_id: NCT06469892
overall_status: COMPLETED
sponsor: Beijing Stomatological Hospital, Capital Medical University
study_type: OBSERVATIONAL
primary_condition: Oral Leukoplakia
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06469892.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06469892"
ct_last_update_post_date: 2024-06-24
last_seen_at: "2026-05-12T06:33:10.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Saliva and Plasma Exosomes for Oral Leukoplakia Malignant Transformation Diagnosis and Oral Cancer Prognosis Monitoring

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

**NCT ID:** [NCT06469892](https://clinicaltrials.gov/study/NCT06469892)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 225
- **Lead Sponsor:** Beijing Stomatological Hospital, Capital Medical University
- **Conditions:** Oral Leukoplakia, Oral Cancer
- **Start Date:** 2020-06-13
- **Completion Date:** 2023-07-30
- **CT.gov Last Update:** 2024-06-24

## 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.

## Eligibility

- **Minimum age:** 30 Years
- **Maximum age:** 80 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## 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.

## Primary Outcomes

- **The expression level of miR-185 in salivary exosomes** _(time frame: 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** _(time frame: 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.

## Locations (1)

- Beijing Stomatological Hospital, Capital Medical University, Beijing, Beijing Municipality, China

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.beijing stomatological hospital, capital medical university|beijing|beijing municipality|china` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06469892.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06469892*  
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