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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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)
Secondary ID [1] 0 0
EPIC-iENE DATA
Universal Trial Number (UTN)
Trial acronym
EPIC-iENE DATA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and Neck Squamous Cell Carcinoma 0 0
Extranodal Extension 0 0
Human Papilloma Virus Related Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Head and neck
Infection 0 0 0 0
Other infectious diseases
Cancer 0 0 0 0
Any cancer

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Extranodal extension

Other interventions: Extranodal extension
Extranodal extension presence or absence on radiology and pathology assessment
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To assess the accuracy of the identification of iENE by radiologists in real world situations by correlating with histopathology (pENE)
Timepoint [1] 0 0
31 December 2023
Primary outcome [2] 0 0
To evaluate the prognostic significance (overall survival rates) of iENE.
Timepoint [2] 0 0
31 December 2023
Primary outcome [3] 0 0
To evaluate the prognostic significance (recurrence rates) of iENE
Timepoint [3] 0 0
31 December 2023
Primary outcome [4] 0 0
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
Timepoint [4] 0 0
31 December 2023
Primary outcome [5] 0 0
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
Timepoint [5] 0 0
31 December 2023
Secondary outcome [1] 0 0
Improve the diagnosis of iENE: Determine radiological features of iENE that best correlate with pENE (the gold standard comparator)
Timepoint [1] 0 0
31 December 2023
Secondary outcome [2] 0 0
Assess the utility of various existing standardized diagnostic classification systems in accurately diagnosing iENE
Timepoint [2] 0 0
31 December 2023
Secondary outcome [3] 0 0
Measure interobserver variability amongst radiologists in grading radiographic ENE and to measure impact of standardized criteria on this variability
Timepoint [3] 0 0
31 December 2023

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

-

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/07/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/09/2023
Sample size
Target
Accrual to date
Final
3500
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Nebraska
Country [2] 0 0
United States of America
State/province [2] 0 0
New York
Country [3] 0 0
United States of America
State/province [3] 0 0
Pennsylvania
Country [4] 0 0
Denmark
State/province [4] 0 0
Copenhagen
Country [5] 0 0
France
State/province [5] 0 0
Paris
Country [6] 0 0
Germany
State/province [6] 0 0
Cologne
Country [7] 0 0
Germany
State/province [7] 0 0
Munich
Country [8] 0 0
Spain
State/province [8] 0 0
Barcelona
Country [9] 0 0
Switzerland
State/province [9] 0 0
Zürich
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Birmingham
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Leeds

Funding & Sponsors
Primary sponsor type
Other
Name
Head and Neck Cancer International Group
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT05936502
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Hisham Mehanna, PhD
Address 0 0
University of Birmingham
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05936502