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

NCT05936502 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3500

Last updated 2024-02-01

No results posted yet for this study

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

Interventions

OTHER

Extranodal extension

Extranodal extension presence or absence on radiology and pathology assessment

Sponsors & Collaborators

  • Head and Neck Cancer International Group

    lead OTHER

Principal Investigators

  • Hisham Mehanna, PhD · University of Birmingham

  • Christina Henson, MD · The University of Oklahoma Health Sciences Center

  • Ahmad K. Abou-Foul, MD · University of Birmingham

  • Paul C Nankivell, PhD · University of Birmingham

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-11
Primary Completion
2023-08-15
Completion
2023-09-30

Countries

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

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05936502 on ClinicalTrials.gov