Randomized Intervention Trial to Evaluate Oral Visual Inspection in the Control of Oral Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 191,873
- 主要终点
- Oral Cancer Death Rate
研究概览
简要总结
Cluster-randomized controlled trial in Trivandrum district, Kerala, India to evaluate the effect of triennial screening for oral cavity cancer using visual inspection on oral cancer mortality.
详细描述
The study population consisted of 13 administrative regions (clusters) in Trivandrum district, Kerala, southern Indian. 7 clusters were randomly assigned to the intervention arm (3 rounds of oral visual inspection conducted 3 years apart) and were compared to the remaining 6 clusters assigned to a control arm that received standard of care. The eligibility criteria were all healthy subjects aged 35 and older, without a personal history of oral cancer. Informed consent was signed by each participant. The intervention arm consisted of 96,517 participants and the control group consisted of 95,356 participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Residing in 13 study clusters in Trivandrum City, Kerala
排除标准
- •Diagnosis with oral cancer prior to study
- •Bedridden subjects
- •Subjects suffering from open tuberculosis or other debilitating diseases
结局指标
主要结局
Oral Cancer Death Rate
时间窗: 15 years
Information on all deaths were collected from the municipal and district death registers, hospital medical records, death records of churches and mosques, hospital visits by the population cancer registry staff and by project health workers. Cancer cases were coded by the ICD-O 3rd edition codes and cause of death was coded using ICD-10 by the registry and project staff blinded to study group allocation. Deaths were attributed to oral cancer if the patient had histologically or clinically confirmed oral cancer, lymph nodes or distant metastasis at the time of death or had died due to complications of oral cancer treatment.
次要结局
- Oral Cavity Cancer Incidence(15 years)