Ascertaining the Radiologic Prognostic Importance of Extranodal Extension on Imaging (iENE) in Head and Neck Cancer Part of the Evaluation Prognostic and Predictive Indicators in Head and Neck Cancer (EPIC) Programme, Run Under the Auspices of the Head and Neck Inter Group (HNCIG, Www.Hncig.Org)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,500
- 试验地点
- 12
- 主要终点
- To assess the accuracy of the identification of iENE by radiologists in real world situations by correlating with histopathology (pENE)
研究概览
简要总结
Extranodal extension (ENE) refers to the spread of head and neck squamous cell carcinoma (HNSCC) outside the lymph nodes. It is a well-known factor that indicates a poorer prognosis and outcome for patients who have undergone surgical removal of the cancer. In such cases, it is recommended to combine chemotherapy with radiation therapy after surgery.
As the number of cases of HNSCC related to the human papillomavirus (HPV) is increasing, treatment approaches have shifted towards using radiation therapy as the primary treatment method instead of surgery. This raises an important question about the significance of ENE observed through imaging tests (referred to as iENE) and its impact on the prognosis. Unfortunately, this question remains unanswered.
The objective of this project is to conduct a comprehensive study across multiple medical institutions. The investigators will gather data including scan results, histopathology reports, and data from patient charts from individuals who have been treated for head and neck cancer. The aim is to analyze and correlate the findings between the pathological evidence of ENE and the imaging results, while also assessing the prognostic value of iENE. Additionally, the investigators will explore the influence of HPV status on these factors.
By collecting and analyzing this data, the investigators hope to establish standardized criteria that can assist radiologists in accurately identifying ENE through imaging tests. This research is essential for enhancing our understanding of HNSCC and improving the effectiveness of diagnostic procedures and treatment planning.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •The investigators will examine data from consecutive patients at each site treated between 1/1/1999 and 12/31/
- •Patients must fulfil all these criteria:
- •i. Been treated for oral cavity, oropharyngeal, carcinoma of unknown primary, laryngeal, or hypopharyngeal squamous cell carcinoma and be over the age of
- •ii. The participants must have been treated with curative intent via surgery, radiotherapy, or chemoradiotherapy or a combination within the study inclusion period.
- •iii. The participants must have had CT or/and MRI scans of the neck, performed within 12 weeks before the start of treatment.
- •iv. Results for the presence or absence of extranodal extension on CT or/and MRI scans, or ability to report them within the deadline period.
- •v. For surgically-treated patients: Results for the presence or absence of both extranodal extension on histopathology and on radiology, or ability to report them within the deadline period.
- •vi. Must have had at least two years of follow-up, or death. vii. Data on staging must be available at least in TNM 7th edition or later editions.
排除标准
- •i. Patients who were diagnosed with distant metastasis at presentation. ii. Patients treated palliatively at first presentation iii. Patients presenting with recurrent disease who don't meet all the eligibility criteria above
结局指标
主要结局
To assess the accuracy of the identification of iENE by radiologists in real world situations by correlating with histopathology (pENE)
时间窗: 31 December 2023
Endpoints: Accuracy of a radiologic "call" of iENE (with pENE being the gold standard comparator) by radiologists not trained for any standardized diagnostic classification systems for iENE.
To evaluate the prognostic significance (overall survival rates) of iENE: Risk stratify HNSCC patients based on presence of radiographic ENE, according to their HPV status and N stage
时间窗: 31 December 2023
Endpoints: Overall survival rates based on presence of various degrees of iENE and pENE
To evaluate the prognostic significance (recurrence rates) of iENE: Risk stratify HNSCC patients based on presence of radiographic ENE, according to their HPV status and N stage
时间窗: 31 December 2023
Endpoints: Recurrence rates based on presence of various degrees of iENE and pENE
To evaluate the prognostic significance (overall survival rates) of iENE.
时间窗: 31 December 2023
Endpoints: Overall survival rates based on presence of iENE and pENE
To evaluate the prognostic significance (recurrence rates) of iENE
时间窗: 31 December 2023
Endpoints: Recurrence rates based on presence of iENE and pENE
次要结局
- Assess the utility of various existing standardized diagnostic classification systems in accurately diagnosing iENE(31 December 2023)
- Measure interobserver variability amongst radiologists in grading radiographic ENE and to measure impact of standardized criteria on this variability(31 December 2023)
- Improve the diagnosis of iENE: Determine radiological features of iENE that best correlate with pENE (the gold standard comparator)(31 December 2023)
研究者
Professor Hisham Mehanna
Professor
Head and Neck Cancer International Group