Ascertaining the Radiologic Prognostic Importance of Extranodal Extension on Imaging (iENE) in Head and Neck Cancer

Head and Neck Squamous Cell Carcinoma Clinical Trial

— EPIC-iENE DATA  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05936502
• Other study ID #: EPIC-iENE DATA
• Status: Completed
• Start date: July 11, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: January 2024
• Source: Head and Neck Cancer International Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3500
• Est. completion date: September 30, 2023
• Est. primary completion date: August 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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. Exclusion Criteria: 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 -

Related Conditions & MeSH terms

• Carcinoma
• Head and Neck Neoplasms
• Head and Neck Squamous Cell Carcinoma
• Papilloma
• Squamous Cell Carcinoma of Head and Neck

Intervention

Other:
• Extranodal extension
Extranodal extension presence or absence on radiology and pathology assessment

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide
Denmark	Copenhagen University Hospitals	Copenhagen
France	Georges Pompidou European Hospital	Paris
Germany	University of Cologne	Cologne
Germany	Technical University of Munich	Munich
Spain	Catalan Institute of Oncology	Barcelona
Switzerland	University Hospital Zürich	Zürich
United Kingdom	University Hospitals Birmingham	Birmingham
United Kingdom	Leeds Teaching Hospitals NHS Trust	Leeds
United States	Mount Sinai Health System	New York	New York
United States	Methodist Estabrook Cancer Center	Omaha	Nebraska
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Head and Neck Cancer International Group

Countries where clinical trial is conducted

United States,  Australia,  Denmark,  France,  Germany,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the accuracy of the identification of iENE by radiologists in real world situations by correlating with histopathology (pENE)	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.	31 December 2023
Primary	To evaluate the prognostic significance (overall survival rates) of iENE.	Endpoints: Overall survival rates based on presence of iENE and pENE	31 December 2023
Primary	To evaluate the prognostic significance (recurrence rates) of iENE	Endpoints: Recurrence rates based on presence of iENE and pENE	31 December 2023
Primary	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	Endpoints: Overall survival rates based on presence of various degrees of iENE and pENE	31 December 2023
Primary	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	Endpoints: Recurrence rates based on presence of various degrees of iENE and pENE	31 December 2023
Secondary	Improve the diagnosis of iENE: Determine radiological features of iENE that best correlate with pENE (the gold standard comparator)	Endpoints: Diagnostic accuracy of various radiographic features of iENE with pENE.	31 December 2023
Secondary	Assess the utility of various existing standardized diagnostic classification systems in accurately diagnosing iENE	Endpoints: Diagnostic accuracy of published standardized classification systems with pENE	31 December 2023
Secondary	Measure interobserver variability amongst radiologists in grading radiographic ENE and to measure impact of standardized criteria on this variability	Endpoints: Interobserver variability measured by Cohen's kappa	31 December 2023