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

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.

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Key information

Conditions

Oral Leukoplakia Disease Head and Neck Neoplasms Leukoplakia Leukoplakia, Oral Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Oral Cancer Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Precancerous Conditions Stomatognathic Diseases

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Stomatological Hospital, Capital Medical University

Beijing, Beijing Municipality, 100010, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Sponsors and collaborators

Lead sponsor

Beijing Stomatological Hospital, Capital Medical University

Other

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2023
Study completion: 2023
First posted: Jun 24, 2024
Registry last updated: Jun 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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