Clinical trial NCT05936502: Ascertaining the Radiologic Prognostic Importance of Extranodal Extension on Imaging (iENE) in Head and Neck Cancer
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Squamous Cell Carcinoma
Extranodal Extension
Human Papilloma Virus Related Carcinoma
Lead sponsor: Head and Neck Cancer International Group
Sponsor class: OTHER
First posted: 2023-07-07
Enrollment: 3500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presented and treated for Head and neck squamous cell carcinoma

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.


Eligibility criteria: 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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Primary outcomes:
measure: To assess the accuracy of the identification of iENE by radiologists in real world situations by correlating with histopathology (pENE)
timeFrame: 31 December 2023
measure: To evaluate the prognostic significance (overall survival rates) of iENE.
timeFrame: 31 December 2023
measure: To evaluate the prognostic significance (recurrence rates) of iENE
timeFrame: 31 December 2023
measure: 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
timeFrame: 31 December 2023
measure: 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
timeFrame: 31 December 2023
Secondary outcomes:
measure: Improve the diagnosis of iENE: Determine radiological features of iENE that best correlate with pENE (the gold standard comparator)
timeFrame: 31 December 2023
measure: Assess the utility of various existing standardized diagnostic classification systems in accurately diagnosing iENE
timeFrame: 31 December 2023
measure: Measure interobserver variability amongst radiologists in grading radiographic ENE and to measure impact of standardized criteria on this variability
timeFrame: 31 December 2023
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Methodist Estabrook Cancer Center
state: Nebraska
city: New York
country: United States
facility: Mount Sinai Health System
state: New York
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospitals
city: Paris
country: France
facility: Georges Pompidou European Hospital
city: Cologne
country: Germany
facility: University of Cologne
city: Munich
country: Germany
facility: Technical University of Munich
city: Barcelona
country: Spain
facility: Catalan Institute of Oncology
city: Zürich
country: Switzerland
facility: University Hospital Zürich
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
Study officials:
affiliation: University of Birmingham
name: Hisham Mehanna, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Oklahoma Health Sciences Center
name: Christina Henson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Birmingham
name: Ahmad K. Abou-Foul, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Birmingham
name: Paul C Nankivell, PhD
role: PRINCIPAL_INVESTIGATOR
References: