Big Data and Models for Personalized Head and Neck Cancer Decision Support (BD2Decide)

Study Overview
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Brief Summary
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The purpose of this study is to determine new multiscale signatures for the prediction of head and neck cancer (HNC) patients disease outcome, in particular for advanced stage (stage III, IV) human papillomavirus (HPV) negative patients and to validate prognostic models for overall survival.

Detailed Description
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The clinical study is devoted to the validation of a decision support system for HNC patients management in the frame of a H2020 project.

Official Title
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Big Data and Models for Personalized Head and Neck Cancer Decision Support (BD2Decide)

Conditions
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Cancer of Head and Neck

Intervention / Treatment
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* Procedure: Standard treatment of SCCHN patients


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent Histologically confirmed diagnosis of oral cavity, oropharynx, larynx, hypopharynx squamous cell carcinoma Clinical stage III and IV Patient candidate for curative treatment: ± surgery ± radiotherapy ± chemotherapy Adequate archival pre-treatment tumor specimen available (FFPE macrodissected sections) Availability of baseline diffusion-weighted imaging (DWI) - Magnetic Resonance Imaging (MRI) acquisition (non-TRACE ) with more than 3 b-values (ranging from 0 (included) to 1000 s/mm2), and a field map acquisition. MRI images, T1 and T2 weighted, (slice thickness lower than 3 mm), head and neck in a single volume, and/or CT scan of the head and neck performed with contiguous cuts of 2-3 mm or less in slice thickness with i.v. contrast Male or female ≥ 18 years old Exclusion Criteria: Any previous haed and neck cancer. Patients with previous malignancies in the last 5 years before treatment for head and neck cancer, with the exception of surgically cured carcinoma in situ of the cervix, in situ breast cancer, incidental finding of stage T1a or T1b prostate cancer, and basal/squamous cell carcinoma of the skin. Any previous malignancy that was treated with surgery and or radiation of the head and neck region. Histological type other than head and neck squamous cell cancer (nasopharynx, salivary glands and sinus nasal cancer are excluded).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Retrospective cohort<br>A total of 1000 SCCHN patients will be enrolled in a retrospective observational study treated in the period 2008-2014. Standard treatment of SCCHN patients The patients will be managed as foreseen by best clinical practice and international guidelines for SCCHN. | Procedure: Standard treatment of SCCHN patients<br>* The interventions may include surgery, radiotherapy, chemotherapy or combined therapies, as recommended by best practice and international guidelines.<br>|
| Prospective cohort<br>A total of 450 SCCHN patients will be enrolled in a study. Each participating Center will select consecutive patients according to the selection criteria (inclusion/exclusion criteria) for one year and will be followed up for two years or more. Standard treatment of SCCHN patients: patients will be administered current best clinical practice treatments. | Procedure: Standard treatment of SCCHN patients<br>* The interventions may include surgery, radiotherapy, chemotherapy or combined therapies, as recommended by best practice and international guidelines.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Realizes and validates an Integrated Decision Support System (BD2Decide platform) | The primary endpoint of this study is the accuracy of the prediction of prognosis based on the BD2Decide platform compared to Tumor Node Metastasis staging (in a population consisting of patients with different subtypes of head and neck cancer). | through study completion, an average of 3 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved Quality of Life | To measure patients' QoL in relation to the new prognostic stratification | baseline, month 6, month 18, month 24 after primary treatment | 
| Assess survival time | Overall survival and disease free survival will be assessed to verify the accuracy of the prediction of BD2Decide platform | at 2, 3 and 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prognostic modelling, radiomics, clinical decision support system, big data analysis, multiscale prognostic signatures, patient-clinician co-decision tools