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NCT Number: NCT05936502

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Extranodal extension

Other

Extranodal extension presence or absence on radiology and pathology assessment

Primary outcomes

  1. 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.

  2. 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

  3. To evaluate the prognostic significance (recurrence rates) of iENE

    Time frame: 31 December 2023

    Endpoints: Recurrence rates based on presence of iENE and pENE

  4. 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

  5. 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

Secondary outcomes

  1. 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.

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Head and Neck Cancer International Group

Other

Registry information

Official study 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)

Acronym: EPIC-iENE DATA

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 7, 2023
Registry last updated
Feb 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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