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

July 11, 2016 updated by: Tito Poli, Azienda Ospedaliero-Universitaria di Parma
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

1450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Dusseldorf, Germany, 40225
        • Recruiting
        • Heinrich-Heine Universitaet Dusseldorf, Dept. of Othorinolaryngology, HHU
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kathrin Scheckenbach, MD, PhD
        • Principal Investigator:
          • Jörg Schipper, MD, PhD
        • Sub-Investigator:
          • Lena Colter, MD, PhD
  • Italy
    • MI
      • Milan, MI, Italy, 20133
        • Recruiting
        • Fondazione Irccs Istituto Dei Tumori Milano
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lisa Licitra, MD, PhD
        • Sub-Investigator:
          • Gemma Gatta, MD, PhD
        • Sub-Investigator:
          • Federica Favales, MD
        • Sub-Investigator:
          • Annalisa Trama, MD, PhD
        • Sub-Investigator:
          • Loris De Cecco, PhD
    • PR
      • Parma, PR, Italy, 43100
        • Recruiting
        • Azienda Ospedaliero Universitaria di Parma
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Enrico M Silini, MD, PhD
        • Principal Investigator:
          • Tito Poli, MD, PhD
        • Sub-Investigator:
          • Giuseppe Maglietta, PhD
        • Sub-Investigator:
          • Caterina Caminiti, PhD
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • Active, not recruiting
        • Stichting VU/VUmc
      • Maastricht, Netherlands, 6229 ET
        • Recruiting
        • Maastricht Radiation Oncology Maastro Clinic
        • Contact:
        • Contact:
        • Principal Investigator:
          • Philippe lambin, MD, PhD
        • Sub-Investigator:
          • Frank Hoebers, MD, PhD
        • Sub-Investigator:
          • Adriana Berlanga, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Retrospective cohort

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Realizes and validates an Integrated Decision Support System (BD2Decide platform)
Time Frame: 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).
through study completion, an average of 3 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improved Quality of Life
Time Frame: baseline, month 6, month 18, month 24 after primary treatment
To measure patients' QoL in relation to the new prognostic stratification
baseline, month 6, month 18, month 24 after primary treatment
Assess survival time
Time Frame: 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
at 2, 3 and 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero-Universitaria di Parma

Collaborators

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Heinrich-Heine University, Duesseldorf
Istituto Superiore di Sanità
Amsterdam UMC, location VUmc
Maastricht Radiation Oncology

Investigators

  • Principal Investigator: Tito Poli, MD, PHD, Azienda Ospedaliero-Universitaria di Parma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (ANTICIPATED)

April 1, 2019

Study Completion (ANTICIPATED)

April 1, 2019

Study Registration Dates

First Submitted

June 1, 2016

First Submitted That Met QC Criteria

July 11, 2016

First Posted (ESTIMATE)

July 14, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

July 14, 2016

Last Update Submitted That Met QC Criteria

July 11, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H2020-PHC30-689715

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patients' data are pseudonymised and stored in a shared Case Report Form (CRF) for data analysis

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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