Big Data and Models for Personalized Head and Neck Cancer Decision Support (BD2Decide)
试验速览
- 阶段
- 不适用
- 入组人数
- 1,450
- 试验地点
- 5
- 主要终点
- Realizes and validates an Integrated Decision Support System (BD2Decide platform)
研究概览
简要总结
The purpose of this study is to determine new multiscale signatures for the prediction of head and neck cancer (HNC) patients disease outcome, in particular for advanced stage (stage III, IV) human papillomavirus (HPV) negative patients and to validate prognostic models for overall survival.
详细描述
The clinical study is devoted to the validation of a decision support system for HNC patients management in the frame of a H2020 project.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
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
- •Signed informed consent
- •Histologically confirmed diagnosis of oral cavity, oropharynx, larynx, hypopharynx squamous cell carcinoma
- •Clinical stage III and IV
- •Patient candidate for curative treatment: ± surgery ± radiotherapy ± chemotherapy
- •Adequate archival pre-treatment tumor specimen available (FFPE macrodissected sections)
- •Availability of baseline diffusion-weighted imaging (DWI) - Magnetic Resonance Imaging (MRI) acquisition (non-TRACE ) with more than 3 b-values (ranging from 0 (included) to 1000 s/mm2), and a field map acquisition.
- •MRI images, T1 and T2 weighted, (slice thickness lower than 3 mm), head and neck in a single volume, and/or CT scan of the head and neck performed with contiguous cuts of 2-3 mm or less in slice thickness with i.v. contrast
- •Male or female ≥ 18 years old
排除标准
- •Any previous haed and neck cancer.
- •Patients with previous malignancies in the last 5 years before treatment for head and neck cancer, with the exception of surgically cured carcinoma in situ of the cervix, in situ breast cancer, incidental finding of stage T1a or T1b prostate cancer, and basal/squamous cell carcinoma of the skin.
- •Any previous malignancy that was treated with surgery and or radiation of the head and neck region.
- •Histological type other than head and neck squamous cell cancer (nasopharynx, salivary glands and sinus nasal cancer are excluded).
结局指标
主要结局
Realizes and validates an Integrated Decision Support System (BD2Decide platform)
时间窗: through study completion, an average of 3 year
The primary endpoint of this study is the accuracy of the prediction of prognosis based on the BD2Decide platform compared to Tumor Node Metastasis staging (in a population consisting of patients with different subtypes of head and neck cancer).
次要结局
- Assess survival time(at 2, 3 and 5 years)
- Improved Quality of Life(baseline, month 6, month 18, month 24 after primary treatment)
研究者
Tito Poli
Professor
Azienda Ospedaliero-Universitaria di Parma