Storage of Head and Neck Tumor Samples in a Biobank for Future Genomic-based Research Aiming at Improved Outcome Prediction: " The Head and Neck Tumor Biobank".
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 419
- 试验地点
- 1
- 主要终点
- Main Study Outcome
研究概览
简要总结
The purpose of the biobank is to enable future genomic based research on this Head and Neck Cancer patient population. The investigators will try to identify tumor factors that will predict cancer-related outcome in order to improve the outcome prediction after treatment in a patient-individualized manner.
详细描述
This is a prospective, non-interventional longitudinal study in patients with HNSCC. Patients will have their normal routine workup including the standard panendoscopy, during which usually multiple biopsies for diagnostic histo-pathology are obtained. Part of one of these biopsies will be stored in the HN Tumor Biobank. There will be no change in the subsequent proposed treatment, which may consist of primary surgery (with or without postoperative (chemo-) radiation) or definitive (chemo-) radiation.
The primary and general objective of this project is to develop, validate, and improve predictive models for different endpoints that are relevant for patients after curatively intended treatment of HNSCC. These endpoints include loco-regional tumour control and overall survival.
Primary Objective: To build a biobank of tumor tissue from all HNSCC patients for future genomic analyses.
Secondary Objective: To improve the outcome prediction, based on both clinical factors and tumour gene expression profiles.
Hypothesis:
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
- •Patient with (suspected) mucosal HNSCC
- •Tumor site: oropharynx, hypopharynx, larynx, nasopharynx, or oral cavity
- •Scheduled for panendoscopy under general anesthesia
- •Tumor size that permits harvesting of multiple biopsies, without risk of functional damage
- •No previous treatment, except previous biopsy
- •Age >= 18 years
排除标准
- •Small primary tumors, e.g. vocal cord tumors, that are too small to obtain multiple biopsies because of the associated risk of functionale damage
- •Patients not undergoing panendoscopy during routine clinical work-up, e.g. because of examination under general anaesthesia already performed elsewhere, before referral to azM.
结局指标
主要结局
Main Study Outcome
时间窗: from enrollment to follow-up at 5 years
Locoregional control and/or survival
次要结局
未报告次要终点