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

Azienda Ospedaliero-Universitaria di Parma

Status: Unknown

Conditions: Cancer of Head and Neck

Treatments: Procedure: Standard treatment of SCCHN patients

Study type: Observational

Funder types: Other

Identifiers

NCT02832102

H2020-PHC30-689715

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,450 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

1,450 participants in 2 patient groups

Retrospective cohort

Description:

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.

Treatment:

Procedure: Standard treatment of SCCHN patients

Prospective cohort

Description:

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.

Treatment:

Procedure: Standard treatment of SCCHN patients