Head and Neck Squamous Cell CarcinomaEPIC-iENE DATANCT05936502
Ascertaining the Radiologic Prognostic Importance of Extranodal Extension on Imaging (iENE) in Head and Neck Cancer
An observational study of Head and Neck Squamous Cell Carcinoma and Extranodal Extension, run by Head and Neck Cancer International Group at 12 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma, Extranodal Extension, Human Papilloma Virus Related Carcinoma
- What is being tested?
- Extranodal extension
- How many people
- 3,500 participants
- Where
- 12 sitesin 8 countries
- Study dates
- 11 Jul 2022to 30 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presented and treated for Head and neck squamous cell carcinoma
Who may be able to join
- 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:
- Been treated for oral cavity, oropharyngeal, carcinoma of unknown primary, laryngeal, or hypopharyngeal squamous cell carcinoma and be over the age of 18.
- The participants must have been treated with curative intent via surgery, radiotherapy, or chemoradiotherapy or a combination within the study inclusion period.
- The participants must have had CT or/and MRI scans of the neck, performed within 12 weeks before the start of treatment.
- Results for the presence or absence of extranodal extension on CT or/and MRI scans, or ability to report them within the deadline period.
- 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.
- 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.
Who cannot join
- 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
- -
Trial locations and contacts
12 sites in 8 countries.
12 sites in 8 countries
United States3 sites
Mount Sinai Health System
New York, New York, 10029
Methodist Estabrook Cancer Center
Omaha, Nebraska, 68114
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Germany2 sites
University of Cologne
Cologne
Technical University of Munich
Munich
United Kingdom2 sites
University Hospitals Birmingham
Birmingham
Leeds Teaching Hospitals NHS Trust
Leeds
About this study
Official 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)
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.
Read more
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
- Head and Neck Squamous Cell Carcinoma, Extranodal Extension, Human Papilloma Virus Related Carcinoma
- Being tested
- Extranodal extension
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Extranodal Extension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extranodal extensionOther
Extranodal extension presence or absence on radiology and pathology assessment
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the accuracy of the identification of iENE by radiologists in real world situations by correlating with histopathology (pENE)
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.
Measured: 31 December 2023
To evaluate the prognostic significance (overall survival rates) of iENE.
Endpoints: Overall survival rates based on presence of iENE and pENE
Measured: 31 December 2023
To evaluate the prognostic significance (recurrence rates) of iENE
Endpoints: Recurrence rates based on presence of iENE and pENE
Measured: 31 December 2023
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
Endpoints: Overall survival rates based on presence of various degrees of iENE and pENE
Measured: 31 December 2023
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
Endpoints: Recurrence rates based on presence of various degrees of iENE and pENE
Measured: 31 December 2023
Secondary outcomes (3)
Improve the diagnosis of iENE: Determine radiological features of iENE that best correlate with pENE (the gold standard comparator)
Endpoints: Diagnostic accuracy of various radiographic features of iENE with pENE.
Measured: 31 December 2023
Assess the utility of various existing standardized diagnostic classification systems in accurately diagnosing iENE
Endpoints: Diagnostic accuracy of published standardized classification systems with pENE
Measured: 31 December 2023
Measure interobserver variability amongst radiologists in grading radiographic ENE and to measure impact of standardized criteria on this variability
Endpoints: Interobserver variability measured by Cohen's kappa
Measured: 31 December 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start11 Jul 2022
- Primary completion15 Aug 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Head and Neck Cancer International Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Hisham Mehanna, Head and Neck Cancer International Group
- Investigators
- Hisham Mehanna, PhD, Principal investigator, University of BirminghamChristina Henson, MD, Principal investigator, The University of Oklahoma Health Sciences CenterAhmad K. Abou-Foul, MD, Principal investigator, University of BirminghamPaul C Nankivell, PhD, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05936502
- Sponsor's protocol ID
- EPIC-iENE DATA
- Acronym
- EPIC-iENE DATA
- Status last verified
- Jan 2024
- First submitted
- 24 May 2023
- Last updated
- 1 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data will bill kept in the HNCIG database, and might be shared with other researchers following a reasonable request (and following agreement by the HNCIG board)
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT05936502
- Acronym / sponsor ID
- EPIC-iENE DATA / EPIC-iENE DATA
- Conditions
- Head and Neck Squamous Cell Carcinoma, Extranodal Extension, Human Papilloma Virus Related Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,500 participants (actual)
- Lead sponsor
- Head and Neck Cancer International GroupUniversity, hospital or other
- Study start
- 11 Jul 2022 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presented and treated for Head and neck squamous cell carcinoma
Key inclusion criteria (7 listed)
- 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:
- Been treated for oral cavity, oropharyngeal, carcinoma of unknown primary, laryngeal, or hypopharyngeal squamous cell carcinoma and be over the age of 18.
- The participants must have been treated with curative intent via surgery, radiotherapy, or chemoradiotherapy or a combination within the study inclusion period.
- The participants must have had CT or/and MRI scans of the neck, performed within 12 weeks before the start of treatment.
- Results for the presence or absence of extranodal extension on CT or/and MRI scans, or ability to report them within the deadline period.
Key exclusion criteria (2 listed)
- 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
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extranodal extensionExtranodal extension presence or absence on radiology and pathology assessment | Other | – |
Primary outcome
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.
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
To evaluate the prognostic significance (recurrence rates) of iENE
Time frame: 31 December 2023
Endpoints: Recurrence rates based on presence of iENE and pENE
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
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
3 secondary outcomes
Improve the diagnosis of iENE: Determine radiological features of iENE that best correlate with pENE (the gold standard comparator)
Time frame: 31 December 2023
Assess the utility of various existing standardized diagnostic classification systems in accurately diagnosing iENE
Time frame: 31 December 2023
Measure interobserver variability amongst radiologists in grading radiographic ENE and to measure impact of standardized criteria on this variability
Time frame: 31 December 2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Individual participant dataSharing planned: Undecided. The data will bill kept in the HNCIG database, and might be shared with other researchers following a reasonable request (and following agreement by the HNCIG board)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hisham Mehanna, PhD principal investigator
University of Birmingham
Christina Henson, MD principal investigator
The University of Oklahoma Health Sciences Center
Ahmad K. Abou-Foul, MD principal investigator
University of Birmingham
12 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Squamous Cell Carcinoma and Extranodal Extension, run by Head and Neck Cancer International Group at 12 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Germany, United Kingdom, Australia, Denmark and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.