Evaluating of Clinical Early Detection of Breast Cancer in Trivandrum District, India
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 115,290
- 主要终点
- Breast Cancer Incidence
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 breast cancer using clinical breast examination on breast cancer mortality.
详细描述
The study population consisted of 274 administrative regions (clusters) in Trivandrum district, Kerala, southern Indian. 133 clusters were randomly assigned to the intervention arm (3 rounds of clinical breast examination conducted 3 years apart) and were compared to the remaining 141 clusters assigned to a control arm that received standard of care. The eligibility criteria were all healthy subjects aged 30 to 69, without a personal history of breast cancer. Informed consent was signed by each participant. The intervention arm consisted of 55,843 participants and the control group consisted of 59,447 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
盲法说明
Cancer registry staff members blinded to study group assignments collected data on the date of diagnosis, stage, treatment and follow-up details of breast cancer patients by visiting hospitals and laboratories where breast cancer cases are diagnosed and treated. The cause of death was assessed by two independent experts blinded to group allocation after evaluation of data from hospital records, death certificates, house visits and interviews of relatives and friends.
入排标准
- 年龄范围
- 30 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Residing in 274 study clusters in Trivandrum City, Kerala
排除标准
- •Diagnosis with breast cancer prior to study
- •Bedridden subjects
- •Subjects suffering from open tuberculosis or other debilitating diseases
结局指标
主要结局
Breast Cancer Incidence
时间窗: 14 years
Information on incident breast cancer cases were obtained from the Trivandrum population-based cancer registry, hospital cancer registry of the RCC and medical records departments of other hospitals treating breast cancer patients. Collection of information was blinded to study group assignment of cases. The staging of breast cancers was done according to the UICC TNM staging system.
Breast Cancer Death Rate
时间窗: 14 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 breast cancer if the patient had histologically or clinically confirmed breast cancer, lymph nodes or distant metastasis at the time of death or had died due to complications of breast cancer treatment.
次要结局
未报告次要终点