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

NCT05936502 | Completed

• 1 other identifier: EPIC-iENE DATA
• Study Type: observational
• Target: 3,500
• Locations: 8 countries
• Sites: 12

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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

• To evaluate the prognostic significance (overall survival rates) of iENE.

  Endpoints: Overall survival rates based on presence of iENE and pENE

  31 December 2023

• To evaluate the prognostic significance (recurrence rates) of iENE

  Endpoints: Recurrence rates based on presence of iENE and pENE

  31 December 2023

• 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

• 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 Outcomes (3)

• Improve the diagnosis of iENE: Determine radiological features of iENE that best correlate with pENE (the gold standard comparator)

  31 December 2023

• 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

Interventions

Extranodal extension OTHER

Extranodal extension presence or absence on radiology and pathology assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presented and treated for Head and neck squamous cell carcinoma

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Head and Neck Cancer International Group: lead

Study Sites (12)

Methodist Estabrook Cancer Center

Omaha, Nebraska, 68114, United States

Location

Mount Sinai Health System

New York, New York, 10029, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Royal Adelaide Hospital

Adelaide, Australia

Location

Copenhagen University Hospitals

Copenhagen, Denmark

Location

Georges Pompidou European Hospital

Paris, France

Location

University of Cologne

Cologne, Germany

Location

Technical University of Munich

Munich, Germany

Location

Catalan Institute of Oncology

Barcelona, Spain

Location

University Hospital Zürich

Zurich, Switzerland

Location

University Hospitals Birmingham

Birmingham, United Kingdom

Location

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Extranodal Extension

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: July 7, 2023
• Study Start: July 11, 2022
• Primary Completion: August 15, 2023
• Study Completion: September 30, 2023
• Last Updated: February 1, 2024

Record last verified: 2024-01

Locations

GB (2); FR (1); DK (1); AU (1); US (3); DE (2); CH (1); ES (1)