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

• Conditions: Cancer of Head and Neck
• Interventions: Procedure: Standard treatment of SCCHN patients

• Registration Number: NCT02832102
• Lead Sponsor: Azienda Ospedaliero-Universitaria di Parma

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.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-06-01
• Status Verified: 2016-07
• Study First Submitted QC: 2016-07-11
• Last Update Submitted: 2016-07-11
• Study First Posted: 2016-07-14
• Last Update Posted: 2016-07-14
• Primary Completion: 2019-04
• Study Completion: 2019-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1450

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Retrospective cohort	Standard treatment of SCCHN patients	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.
Prospective cohort	Standard treatment of SCCHN patients	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (5)

Heinrich-Heine Universitaet Dusseldorf, Dept. of Othorinolaryngology, HHU; 🇩🇪 Dusseldorf, Germany

Fondazione Irccs Istituto Dei Tumori Milano; 🇮🇹 Milan, MI, Italy

Maastricht Radiation Oncology MAASTRO Clinic; 🇳🇱 Maastricht, Netherlands

Azienda Ospedaliero Universitaria di Parma; 🇮🇹 Parma, PR, Italy

Stichting VU/VUmc; 🇳🇱 Amsterdam, Netherlands