NCT05766150招募中不适用
Association Between Oral Microbioma With Developing of Oral (Pre)Malignant Disease.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Association between oral microbioma and (pre)malignant disease.
研究概览
简要总结
This case-control study aims to investigate if oral microbioma is associated with developing oral (pre)malignant disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥18 years in case of oral malignancy or premalignant disease, ≥40 years in case of no malignant disease
- •Patients are (partially) dentate (≥20 teeth)
- •Patients who have given written informed consent to participate in this study
排除标准
- •Patients with a history of radiotherapy in head and neck region
- •Patients with a history of chemotherapy, immunotherapy or immunomodulating drugs
- •Patients with a previous malginancy in head and neck region
- •Edentulous patients (with or without implants)
- •Patients with removable (partial) dentures
结局指标
主要结局
Association between oral microbioma and (pre)malignant disease.
时间窗: Through study completion, an average of 3 years
Prevalence of clusters of different oral pathogens will be displayed for patients with malignant disease, premalignant disease and no oral malignancy. Taxonomic representation of statistically and biologically consistent differences between patients with malignant disease, premalignant disease and no oral malignant disease will be displayed.
次要结局
- To describe the difference in oral microbioma between young (>40 years) patients with oral SCC and older (>40 years) patients with oral squamous cell carcinoma.(Through study completion, an average of 3 years)
- To desribe the difference in oral microbioma and stage of disease upon presentation.(Through study completion, an average of 3 years)
研究者
Eliza Hagens
Drs. L.A.A. Vaassen & Dr. E.R.C. Hagens
Academisch Ziekenhuis Maastricht
研究点 (2)
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