Cancer of Head and Neck
Conditions
Keywords
prognostic modelling, radiomics, clinical decision support system, big data analysis, multiscale prognostic signatures, patient-clinician co-decision tools
Brief summary
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
The clinical study is devoted to the validation of a decision support system for HNC patients management in the frame of a H2020 project.
Interventions
PROCEDUREStandard treatment of SCCHN patients
The interventions may include surgery, radiotherapy, chemotherapy or combined therapies, as recommended by best practice and international guidelines.
Sponsors
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Amsterdam UMC, location VUmc
Heinrich-Heine University, Duesseldorf
Maastricht Radiation Oncology
Istituto Superiore di Sanità
Azienda Ospedaliero-Universitaria di Parma
Study design
Observational model
COHORT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Realizes and validates an Integrated Decision Support System (BD2Decide platform) | through study completion, an average of 3 year | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improved Quality of Life | baseline, month 6, month 18, month 24 after primary treatment | To measure patients' QoL in relation to the new prognostic stratification |
| Assess survival time | at 2, 3 and 5 years | Overall survival and disease free survival will be assessed to verify the accuracy of the prediction of BD2Decide platform |
Countries
Germany, Italy, Netherlands
Contacts
Primary ContactTito Poli, MD, PhD
Backup ContactLisa Licitra, MD, PhD
Outcome results
None listed