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

Cancer of Head and Neck Clinical Trial

— BD2Decide  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02832102
• Other study ID #: H2020-PHC30-689715
• Status: Recruiting
• Phase: N/A
• First received: June 1, 2016
• Last updated: July 11, 2016
• Start date: April 2016
• Est. completion date: April 2019

Study information

• Verified date: July 2016
• Source: Azienda Ospedaliero-Universitaria di Parma
• Contact: Tito Poli, MD, PhD
• Phone: +39052170
• Email: tito.poli[@]unipr.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1450
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort

Related Conditions & MeSH terms

• Cancer of Head and Neck
• Head and Neck Neoplasms

Intervention

Procedure:
• Standard treatment of SCCHN patients
The interventions may include surgery, radiotherapy, chemotherapy or combined therapies, as recommended by best practice and international guidelines.

Locations

Country	Name	City	State
Germany	Heinrich-Heine Universitaet Dusseldorf, Dept. of Othorinolaryngology, HHU	Dusseldorf
Italy	Fondazione Irccs Istituto Dei Tumori Milano	Milan	MI
Italy	Azienda Ospedaliero Universitaria di Parma	Parma	PR
Netherlands	Stichting VU/VUmc	Amsterdam
Netherlands	Maastricht Radiation Oncology MAASTRO Clinic	Maastricht

Sponsors (6)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria di Parma	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Heinrich-Heine University, Duesseldorf, Istituto Superiore di Sanità, Maastricht Radiation Oncology, VU University Medical Center

Countries where clinical trial is conducted

Germany,  Italy,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No