Clinical trial NCT02832102: Big Data and Models for Personalized Head and Neck Cancer Decision Support (BD2Decide)
Official title: Big Data and Models for Personalized Head and Neck Cancer Decision Support (BD2Decide)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer of Head and Neck
Keywords: prognostic modelling
radiomics
clinical decision support system
big data analysis
multiscale prognostic signatures
patient-clinician co-decision tools
Lead sponsor: Azienda Ospedaliero-Universitaria di Parma
Sponsor class: OTHER
Collaborators: name: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
name: Amsterdam UMC, location VUmc
name: Heinrich-Heine University, Duesseldorf
name: Maastricht Radiation Oncology
name: Istituto Superiore di Sanità
First posted: 2016-07-14
Enrollment: 1450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prospective study cohort: A total of 450 SCCHN patients Stage III and IV, followed up for 18-24 months or more.

Retrospective study cohort: A total of 1000 SCCHN patients Stage III and IV, diagnosed between year 2008 and 2014.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Realizes and validates an Integrated Decision Support System (BD2Decide platform)
timeFrame: through study completion, an average of 3 year
Secondary outcomes:
measure: Improved Quality of Life
timeFrame: baseline, month 6, month 18, month 24 after primary treatment
measure: Assess survival time
timeFrame: at 2, 3 and 5 years
Other outcomes:
Locations:
city: Dusseldorf
country: Germany
facility: Heinrich-Heine Universitaet Dusseldorf, Dept. of Othorinolaryngology, HHU
city: Milan
country: Italy
facility: Fondazione Irccs Istituto Dei Tumori Milano
state: MI
city: Parma
country: Italy
facility: Azienda Ospedaliero Universitaria di Parma
state: PR
city: Amsterdam
country: Netherlands
facility: Stichting VU/VUmc
city: Maastricht
country: Netherlands
facility: Maastricht Radiation Oncology MAASTRO Clinic
Study officials:
affiliation: Azienda Ospedaliero-Universitaria di Parma
name: Tito Poli, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cavalieri S, Serafini MS, Carenzo A, Canevari S, Brakenhoff RH, Leemans CR, Nauta IH, Hoebers F, van den Hout MFCM, Scheckenbach K, Hoffmann TK, Ardighieri L, Poli T, Quattrone P, Locati LD, Licitra L, De Cecco L. Clinical Validity of a Prognostic Gene Expression Cluster-Based Model in Human Papillomavirus-Positive Oropharyngeal Carcinoma. JCO Precis Oncol. 2021 Oct 27;5:PO.21.00094. doi: 10.1200/PO.21.00094. eCollection 2021.