Clinical trial NCT06469892: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Leukoplakia
Oral Cancer
Keywords: Oral cancer
Oral leukoplakia
Exosome
miR-185
Diagnosis
Prognosis
Lead sponsor: Beijing Stomatological Hospital, Capital Medical University
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 225
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants were from the Department of Stomatology, Beijing Stomatological Hospital, Capital Medical University, Beijing, China.

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 criteria: 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.

Primary outcomes:
measure: The expression level of miR-185 in salivary exosomes
timeFrame: Baseline, pre-biopsy surgery.
measure: The expression level of miR-185 in plasma exosomes
timeFrame: Baseline, pre-biopsy surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Stomatological Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Stomatological Hospital, Capital Medical University
name: Xiaobing Guan, Ph.D.
role: STUDY_DIRECTOR
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