Application of Salivary and Plasma Exosomes in the Diagnosis of Oral Leukoplakia Malignant Transformation and Prognosis Monitoring of Oral Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- The expression level of miR-185 in salivary exosomes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
The expression level of miR-185 in salivary exosomes
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Xiaobing Guan
Doctor and Professor of Oral Medicine，and Director of Department of Oral Medicine
Beijing Stomatological Hospital, Capital Medical University