The Children and Adolescents Nasopharyngeal Carcinoma Survivor Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 主要终点
- Overall survival(OS)
研究概览
简要总结
The Children and Adolescents Nasopharyngeal Carcinoma Survivor Study will investigate the long-term effects of nasopharyngeal carcinoma (NPC) and its associated therapies. A prospective and retrospective cohort study will be conducted through a multi-institutional collaboration. This project will study children and adolescents exposed to specific therapeutic modalities, including radiation, chemotherapy, and/or surgery, who are at increased risk of late-occurring adverse health outcomes. A group of sibling controls will be identified and data collected for comparison purposes.
详细描述
The study will focus on the following objectives:
- Characterize survivors' health with respect to disease- and treatment-related factors.
- Investigate the consequences of various intensities of exposure to chemotherapy and/or radiation on health outcomes (e.g., cardiovascular, reproductive, second cancers, etc...).
- Compare the mortality experience of survivors with the general population.
- Characterize the health-related behaviors, patterns of medical care, and medical follow-up needs of survivors.
- Describe patterns of familial aggregation of cancer, including known (and variations of) cancer family syndromes.
- Collect and store biologic samples (saliva, blood, second tumor tissue) to correlate with health outcomes and use for future research.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients or their siblings must be informed of the investigational nature of this study and give written informed consent.
- •Patients with histologically confirmed non-keratinizing nasopharyngeal carcinoma (including differentiated type and undifferentiated type, WHO II or III) before age 21 years at one of participating centers.
排除标准
- •Already involved in other blind clinical trial.
- •The information of tumour response evaluation and survival data cannot be obtained.
结局指标
主要结局
Overall survival(OS)
时间窗: 5 years
The OS was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.
次要结局
- Progress-free survival(PFS)(5 years)
- Locoregional failure-free survival(LRFS)(5 years)
- Short-term toxic effects assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0)(3 months)
- Distant metastasis-free survival(DMFS)(5 years)
研究者
Hai-Qiang Mai,MD,PhD
Hai-Qiang Mai
Sun Yat-sen University