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

Sponsor

Head and Neck Cancer International Group (Other)

Overall Status

Recruiting

CT.gov ID

NCT05936502

Collaborator

(none)

2,000

Enrollment

Locations

5.7

Anticipated Duration (Months)

166.7

Patients Per Site

29.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Squamous Cell Carcinoma Extranodal Extension Human Papilloma Virus Related Carcinoma	Other: Extranodal extension

Study Design

Study Type:

Observational

Anticipated Enrollment :

2000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

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)

Actual Study Start Date :

Jul 11, 2023

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Outcome Measures

Primary Outcome Measures

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. [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
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

Secondary Outcome Measures

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.
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

Been treated for oral cavity, oropharyngeal, carcinoma of unknown primary, laryngeal, or hypopharyngeal squamous cell carcinoma and be over the age of 18.
The participants must have been treated with curative intent via surgery, radiotherapy, or chemoradiotherapy or a combination within the study inclusion period.
The participants must have had CT or/and MRI scans of the neck, performed within 12 weeks before the start of treatment.
Results for the presence or absence of extranodal extension on CT or/and MRI scans, or ability to report them within the deadline period.
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.
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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Methodist Estabrook Cancer Center	Omaha	Nebraska	United States	68114
2	Mount Sinai Health System	New York	New York	United States	10029
3	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213
4	Royal Adelaide Hospital	Adelaide		Australia
5	Copenhagen University Hospitals	Copenhagen		Denmark
6	Georges Pompidou European Hospital	Paris		France
7	University of Cologne	Cologne		Germany
8	Technical University of Munich	Munich		Germany
9	Catalan Institute of Oncology	Barcelona		Spain
10	University Hospital Zürich	Zürich		Switzerland
11	University Hospitals Birmingham	Birmingham		United Kingdom
12	Leeds Teaching Hospitals NHS Trust	Leeds		United Kingdom

Sponsors and Collaborators

Head and Neck Cancer International Group

Investigators

Principal Investigator: Hisham Mehanna, PhD, University of Birmingham
Principal Investigator: Christina Henson, MD, The University of Oklahoma Health Sciences Center
Principal Investigator: Ahmad K. Abou-Foul, MD, University of Birmingham
Principal Investigator: Paul C Nankivell, PhD, University of Birmingham