Natural History Of Oral Cancer Precursor Lesions: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,576
- 试验地点
- 4
- 主要终点
- Progression to dysplasia/cancer in participants with oral precursors.
研究概览
简要总结
Background:
- Cancer of the mouth and throat is one of the most common cancers in Taiwan. This cancer develops over several years, beginning as white or red patches in the mouth or throat that become growths. It can also cause a condition that leads to rigidity of the cheeks. The growths can be identified when a doctor looks into a person s mouth. It is currently not clear why some people with abnormal growths progress to cancer while others do not. Researchers want to better understand why some patients with early abnormal growths get late abnormal growths. They also want to understand why some people get abnormal growths again, even after they receive treatment.
Objectives:
- To understand why some people with precancerous lesions in their mouth develop cancer while others do not.
Eligibility:
- Adults 21 years and older, some with abnormal growths in the mouth, some without any, and some with head and neck cancer.
Design:
- Participants will visit a hospital in Taiwan 2 times.
- At the first visit, participants will answer questions about their health, lifestyle, and family medical history. A doctor will examine the participant s mouth and take a small piece of any growth they see. They will do this with a brush. They will also photograph the participant s mouth. Participants will also give blood and saliva samples, plus a small sample of a mouth rinse.
- Participants who are diagnosed with a late abnormal growth that is not cancer will return for a second visit. They will answer the same questions and undergo the same procedures as at the first study.
详细描述
Oral cancers are ideal candidates for screening, early detection, and secondary prevention given the amenability for visual inspection and specimen collection and the availability of recognized precursors. Yet, there are currently no guidelines for screening, treatment, or follow-up of patients with oral cancer precursors, in part, owing to the current gaps in knowledge regarding the natural history of precursor lesions. We propose to conduct a prospective cohort study of patients with oral cancer precursors to address these knowledge gaps and to investigate novel etiologic factors.
In preparation for the cohort study, we recently conducted a pilot study in Taiwan, a country with high oral cancer incidence. This pilot was aimed to streamline field operations and collect preliminary data to aid in the design of the cohort study. As detailed in our concept, we successfully accomplished all of the goals of our pilot study, including successful recruitment and retention of patients as well as the collection of critical preliminary data.
Based on these efforts, we are seeking approval to conduct a prospective cohort study of 3000 patients with precursors to investigate the natural history of histologically-defined oral cancer precursor lesions and evaluate epidemiologic/ molecular predictors for progression. After completion of the recruitment period, we plan to recruit an additional 500 patients with clinically-defined precancerous lesions for passive follow-up. The prospective component will be complemented by cross-sectional comparisons of epidemiologic/molecular factors across 750 controls, 3500 precursors, and 750 cancers.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 21 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Progression to dysplasia/cancer in participants with oral precursors.
时间窗: Follow-up visits every 6 months for 5 years
Histologically confirmed progression to dysplasia/cancer in participants with oral precursors.
次要结局
未报告次要终点