Ascertaining the Radiologic Prognostic Importance of Extranodal Extension on Imaging (iENE) in Head and Neck Cancer
- Conditions
- Human Papilloma Virus Related CarcinomaHead and Neck Squamous Cell CarcinomaExtranodal Extension
- Registration Number
- NCT05936502
- Lead Sponsor
- Head and Neck Cancer International Group
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3500
The investigators will examine data from consecutive patients at each site treated between 1/1/1999 and 12/31/2020. 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 18.
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.
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the accuracy of the identification of iENE by radiologists in real world situations by correlating with histopathology (pENE) 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 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 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. 31 December 2023 Endpoints: Overall survival rates based on presence of iENE and pENE
To evaluate the prognostic significance (recurrence rates) of iENE 31 December 2023 Endpoints: Recurrence rates based on presence of iENE and pENE
- Secondary Outcome Measures
Name Time Method Assess the utility of various existing standardized diagnostic classification systems in accurately diagnosing iENE 31 December 2023 Endpoints: Diagnostic accuracy of published standardized classification systems with pENE
Measure interobserver variability amongst radiologists in grading radiographic ENE and to measure impact of standardized criteria on this variability 31 December 2023 Endpoints: Interobserver variability measured by Cohen's kappa
Improve the diagnosis of iENE: Determine radiological features of iENE that best correlate with pENE (the gold standard comparator) 31 December 2023 Endpoints: Diagnostic accuracy of various radiographic features of iENE with pENE.
Trial Locations
- Locations (12)
University Hospital Zürich
🇨🇭Zürich, Switzerland
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Methodist Estabrook Cancer Center
🇺🇸Omaha, Nebraska, United States
University Hospitals Birmingham
🇬🇧Birmingham, United Kingdom
Royal Adelaide Hospital
🇦🇺Adelaide, Australia
Mount Sinai Health System
🇺🇸New York, New York, United States
Georges Pompidou European Hospital
🇫🇷Paris, France
Catalan Institute of Oncology
🇪🇸Barcelona, Spain
University of Cologne
🇩🇪Cologne, Germany
Copenhagen University Hospitals
🇩🇰Copenhagen, Denmark
Technical University of Munich
🇩🇪Munich, Germany
Leeds Teaching Hospitals NHS Trust
🇬🇧Leeds, United Kingdom