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Clinical trialNCT05936502CompletedObservational

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

SponsorHead and Neck Cancer International GroupEnrollment3,500Extranodal ExtensionHead and Neck Squamous Cell CarcinomaHuman Papilloma Virus Related Carcinoma
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

12 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Australia
  • Royal Adelaide Hospital

    Adelaide, Australia

Denmark
  • Copenhagen University Hospitals

    Copenhagen, Denmark

France
  • Georges Pompidou European Hospital

    Paris, France

Germany
  • University of Cologne

    Cologne, Germany

  • Technical University of Munich

    Munich, Germany

Spain
  • Catalan Institute of Oncology

    Barcelona, Spain

Switzerland
  • University Hospital Zürich

    Zurich, Switzerland

United Kingdom
  • University Hospitals Birmingham

    Birmingham, United Kingdom

  • Leeds Teaching Hospitals Nhs Trust

    Leeds, United Kingdom

United States
  • Methodist Estabrook Cancer Center

    Omaha, Nebraska, United States

  • Mount Sinai Health System

    New York, New York, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
11 Jul 2022
Primary completion
15 Aug 2023
Completion
30 Sept 2023
Last update posted
1 Feb 2024
Registered enrollment
3,500
Registry id
NCT05936502

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.