CompletedNot Applicable

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

China225 participantsStarted 2020-06-13

Plain-language 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.

Who can participate

Age range

30 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The expression level of miR-185 in salivary exosomes

Timeframe: Baseline, pre-biopsy surgery.

The expression level of miR-185 in plasma exosomes

Timeframe: Baseline, pre-biopsy surgery.

Trial details

NCT IDNCT06469892

SponsorBeijing Stomatological Hospital, Capital Medical University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-06-30

View on ClinicalTrials.gov More Oral Leukoplakia trials