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

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ClinicalTrials.gov Identifier: NCT02832102
Recruitment Status : Recruiting
First Posted : July 14, 2016
Last Update Posted : July 14, 2016
Sponsor:
Collaborators:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
VU University Medical Center
Heinrich-Heine University, Duesseldorf
Maastricht Radiation Oncology
Istituto Superiore di Sanità
Information provided by (Responsible Party):
Tito Poli, 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.

Condition or disease Intervention/treatment
Cancer of Head and Neck Procedure: Standard treatment of SCCHN patients

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
Estimated Enrollment : 1450 participants
Observational Model: Cohort
Official Title: Big Data and Models for Personalized Head and Neck Cancer Decision Support (BD2Decide)
Study Start Date : April 2016
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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

  2. 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


Biospecimen Retention:   Samples With DNA
FFPE tumor specimens


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02832102


Contacts
Contact: Tito Poli, MD, PhD +39052170 ext 3613 tito.poli@unipr.it
Contact: Lisa Licitra, MD, PhD +39 022390 ext 2150 lisa.licitra@istitutotumori.mi.it

Locations
Germany
Heinrich-Heine Universitaet Dusseldorf, Dept. of Othorinolaryngology, HHU Recruiting
Dusseldorf, Germany, 40225
Contact: Kathrin Scheckenbach, MD, PhD    +4981211811 ext 7570    Scheckenbach@med.uni-duesseldorf.de   
Contact: Lena Colter, MD, PhD       Lena.Colter@med.uni-duesseldorf.de   
Principal Investigator: Kathrin Scheckenbach, MD, PhD         
Principal Investigator: Jörg Schipper, MD, PhD         
Sub-Investigator: Lena Colter, MD, PhD         
Italy
Fondazione Irccs Istituto Dei Tumori Milano Recruiting
Milan, MI, Italy, 20133
Contact: LISA LICITRA, MD, PhD    +39 022390 ext 2150    lisa.licitra@istitutotumori.mi.it   
Contact: Federica Favales    +39 022390 ext 3287    federica.favales@istitutotumori.mi.it   
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         
Azienda Ospedaliero Universitaria di Parma Recruiting
Parma, PR, Italy, 43100
Contact: TITO POLI, MD, PhD    +390521703109    tito.poli@unipr.it   
Contact: Davide Lanfranco, MD, PhD    +390521703109    lanfranco82@yahoo.it   
Sub-Investigator: Enrico M Silini, MD, PhD         
Principal Investigator: Tito Poli, MD, PhD         
Sub-Investigator: Giuseppe Maglietta, PhD         
Sub-Investigator: Caterina Caminiti, PhD         
Netherlands
Stichting VU/VUmc Active, not recruiting
Amsterdam, Netherlands, 1081 HV
Maastricht Radiation Oncology MAASTRO Clinic Recruiting
Maastricht, Netherlands, 6229 ET
Contact: Philippe lambin, MD, PhD    +31 88 445 5585    philippe.lambin@maastro.nl   
Contact: Frank Hoebers, MD, PhD    +31 88 4455666    frank.hoebers@maastro.nl   
Principal Investigator: Philippe lambin, MD, PhD         
Sub-Investigator: Frank Hoebers, MD, PhD         
Sub-Investigator: Adriana Berlanga, MD, PhD         
Sponsors and Collaborators
Azienda Ospedaliero-Universitaria di Parma
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
VU University Medical Center
Heinrich-Heine University, Duesseldorf
Maastricht Radiation Oncology
Istituto Superiore di Sanità
Investigators
Principal Investigator: Tito Poli, MD, PHD Azienda Ospedaliero-Universitaria di Parma

Responsible Party: Tito Poli, Professor, Azienda Ospedaliero-Universitaria di Parma
ClinicalTrials.gov Identifier: NCT02832102     History of Changes
Other Study ID Numbers: H2020-PHC30-689715
First Posted: July 14, 2016    Key Record Dates
Last Update Posted: July 14, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patients' data are pseudonymised and stored in a shared Case Report Form (CRF) for data analysis

Keywords provided by Tito Poli, Azienda Ospedaliero-Universitaria di Parma:
prognostic modelling
radiomics
clinical decision support system
big data analysis
multiscale prognostic signatures
patient-clinician co-decision tools

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms