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

• ClinicalTrials.gov Identifier: NCT05936502
• Recruitment Status: Completed
• First Posted: July 7, 2023
• Last Update Posted: February 1, 2024
• Sponsor: Head and Neck Cancer International Group
• Information provided by (Responsible Party): Professor Hisham Mehanna, Head and Neck Cancer International Group

Tracking Information

• First Submitted Date: May 24, 2023
• First Posted Date: July 7, 2023
• Last Update Posted Date: February 1, 2024
• Actual Study Start Date: July 11, 2022
• Actual Primary Completion Date: August 15, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 6, 2023)

• To assess the accuracy of the identification of iENE by radiologists in real world situations by correlating with histopathology (pENE) [ Time Frame: 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. [ Time Frame: 31 December 2023 ]
  Endpoints: Overall survival rates based on presence of iENE and pENE
• To evaluate the prognostic significance (recurrence rates) of iENE [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 31 December 2023 ]
  Endpoints: Recurrence rates based on presence of various degrees of iENE and pENE

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 6, 2023)

• Improve the diagnosis of iENE: Determine radiological features of iENE that best correlate with pENE (the gold standard comparator) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 31 December 2023 ]
  Endpoints: Interobserver variability measured by Cohen's kappa

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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 Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Patients presented and treated for Head and neck squamous cell carcinoma

Condition

• Head and Neck Squamous Cell Carcinoma
• Extranodal Extension
• Human Papilloma Virus Related Carcinoma

Intervention

Other: Extranodal extension

Extranodal extension presence or absence on radiology and pathology assessment

• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 31, 2024): 3500
• Original Estimated Enrollment (submitted: July 6, 2023): 2000
• Actual Study Completion Date: September 30, 2023
• Actual Primary Completion Date: August 15, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

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Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Denmark, France, Germany, Spain, Switzerland, United Kingdom, United States

Administrative Information

• NCT Number: NCT05936502
• Other Study ID Numbers: EPIC-iENE DATA
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided
• Plan Description: The data will bill kept in the HNCIG database, and might be shared with other researchers following a reasonable request (and following agreement by the HNCIG board)

• Current Responsible Party: Professor Hisham Mehanna, Head and Neck Cancer International Group
• Original Responsible Party: Same as current
• Current Study Sponsor: Head and Neck Cancer International Group
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

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

• PRS Account: Head and Neck Cancer International Group
• Verification Date: January 2024