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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05936502
Registration number
NCT05936502
Ethics application status
Date submitted
24/05/2023
Date registered
7/07/2023
Date last updated
1/02/2024
Titles & IDs
Public title
Ascertaining the Radiologic Prognostic Importance of Extranodal Extension on Imaging (iENE) in Head and Neck Cancer
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Scientific 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)
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Secondary ID [1]
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EPIC-iENE DATA
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Universal Trial Number (UTN)
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Trial acronym
EPIC-iENE DATA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Head and Neck Squamous Cell Carcinoma
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Extranodal Extension
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Human Papilloma Virus Related Carcinoma
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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Kidney
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Cancer
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Head and neck
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Infection
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Other infectious diseases
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Cancer
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Any cancer
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Other interventions - Extranodal extension
Other interventions: Extranodal extension
Extranodal extension presence or absence on radiology and pathology assessment
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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To assess the accuracy of the identification of iENE by radiologists in real world situations by correlating with histopathology (pENE)
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Assessment method [1]
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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.
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Timepoint [1]
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31 December 2023
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Primary outcome [2]
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To evaluate the prognostic significance (overall survival rates) of iENE.
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Assessment method [2]
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Endpoints: Overall survival rates based on presence of iENE and pENE
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Timepoint [2]
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31 December 2023
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Primary outcome [3]
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To evaluate the prognostic significance (recurrence rates) of iENE
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Assessment method [3]
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Endpoints: Recurrence rates based on presence of iENE and pENE
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Timepoint [3]
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31 December 2023
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Primary outcome [4]
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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
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Assessment method [4]
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Endpoints: Overall survival rates based on presence of various degrees of iENE and pENE
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Timepoint [4]
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31 December 2023
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Primary outcome [5]
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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
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Assessment method [5]
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Endpoints: Recurrence rates based on presence of various degrees of iENE and pENE
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Timepoint [5]
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31 December 2023
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Secondary outcome [1]
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Improve the diagnosis of iENE: Determine radiological features of iENE that best correlate with pENE (the gold standard comparator)
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Assessment method [1]
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Endpoints: Diagnostic accuracy of various radiographic features of iENE with pENE.
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Timepoint [1]
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31 December 2023
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Secondary outcome [2]
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Assess the utility of various existing standardized diagnostic classification systems in accurately diagnosing iENE
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Assessment method [2]
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Endpoints: Diagnostic accuracy of published standardized classification systems with pENE
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Timepoint [2]
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31 December 2023
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Secondary outcome [3]
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Measure interobserver variability amongst radiologists in grading radiographic ENE and to measure impact of standardized criteria on this variability
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Assessment method [3]
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Endpoints: Interobserver variability measured by Cohen's kappa
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Timepoint [3]
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31 December 2023
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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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Study design
Purpose
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Duration
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Selection
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Timing
Retrospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
11/07/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/09/2023
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Sample size
Target
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Accrual to date
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Final
3500
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Royal Adelaide Hospital - Adelaide
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Recruitment postcode(s) [1]
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- Adelaide
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Nebraska
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Country [2]
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United States of America
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State/province [2]
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New York
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Country [3]
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United States of America
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State/province [3]
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Pennsylvania
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Country [4]
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Denmark
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State/province [4]
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Copenhagen
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Country [5]
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France
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State/province [5]
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Paris
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Country [6]
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Germany
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State/province [6]
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Cologne
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Country [7]
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Germany
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State/province [7]
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Munich
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Country [8]
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Spain
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State/province [8]
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Barcelona
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Country [9]
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Switzerland
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State/province [9]
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Zürich
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Country [10]
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United Kingdom
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State/province [10]
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Birmingham
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Country [11]
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United Kingdom
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State/province [11]
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Leeds
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Funding & Sponsors
Primary sponsor type
Other
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Name
Head and Neck Cancer International Group
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05936502
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Hisham Mehanna, PhD
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Address
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University of Birmingham
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05936502
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