Predictive Models for Radiation-induced Side Effects in Head and Neck Cancer Based on Single Nucleotide Polymorphisms (SNP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Change in patient-rated symptoms
研究概览
简要总结
Background of the study:
Swallowing dysfunction and xerostomia are the most frequently reported radiation-induced side effects (RISE) after (chemo) radiation ((CH) RT) in head and neck cancer (HNC) patients and have a major impact on the general dimensions of quality of life (QoL). In radiation0oncology, normal tissue complication probability (NTCP) models based on dose-volume parameters being used to determine the risk of acute and late RISE. NTCP models containing genetic determinants of radiosensitivity, such as single nucleotide polymorphisms (SNPs), may improve model performance and thus enable more individualized radiotherapy. Information of the predictive value of SNPs or SNP signatures among patients with HNC is currently not available.
Objective of the study:
The main objective of this project will be to test the hypothesis that SNP profiles can improve the performance of predictive models for the most frequently reported late RISE, i.e. dysphagia, in HNC patients after curative (CH) RT. Secondary objectives will be improvement of NTCP models for HNC patients by adding SNP profiles predictive of (1) acute mucositis; (2) acute dysphagia; (3) salivary dysfunction; (4) acute xerostomia; (5) late xerostomia; (6) osteoradionecrosis; (7) hypothyroidism; (8) patient-rated HNC symptoms and ; (9) quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological proven head and neck cancer
- •Primary site in the oral cavity, oropharynx, hypopharynx, nasopharynx, paranasal sinuses, and/or salivary glands
- •Treatment with curative intent with primary or postoperative radiotherapy either or not combined with systemic treatment
- •Northern European ethnicity (ethnicity is a known confounder in SNP association studies)
- •Willing and able to comply with the study prescriptions
- •18 years or older
- •No prior radiation (in the head and neck area)
- •Patients must have sufficient knowledge of the Dutch language to understand the meaning of the study as described in the patient information
- •Have given written informed consent before patient registration
排除标准
- •Prior radiotherapy
结局指标
主要结局
Change in patient-rated symptoms
时间窗: At 1,2,3,4,5,6,7 and 12 weeks after first day of radiation therapy
Assessed by questionnaires
Change in patient-rated Quality-of-Life
时间窗: At 6,12,18,24,36,48,60 months after last day of completion of treatment
Assessed by questionnaires
Change in acute toxicity
时间窗: At 1,2,3,4,5,6,7 and 12 weeks after first day of radiation therapy
Dysphagia; mucositis; salivary dysfunction; xerostomia
Change in late toxicity
时间窗: At 6,12,18,24,36,48,60 months after last day of completion of treatment
Dysphagia; xerostomia; osteoradionecrosis; hypothyroidism
次要结局
未报告次要终点