Cancer of Head and NeckBD2DecideNCT02832102
Big Data and Models for Personalized Head and Neck Cancer Decision Support (BD2Decide)
An observational study of Cancer of Head and Neck, run by Azienda Ospedaliero-Universitaria di Parma at 5 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Head and Neck
- What is being tested?
- Standard treatment of SCCHN patients
- Type of treatment
- Surgery or procedure
- How many people
- 1,450 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Apr 2016to Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Italy2 sites, 2 recruiting
- Recruiting
Fondazione Irccs Istituto Dei Tumori Milano
Milan, MI, 20133
LISA LICITRA, MD, PhD, +39 022390 ext. 2150, lisa.licitra@istitutotumori.mi.it
Federica Favales, +39 022390 ext. 3287, federica.favales@istitutotumori.mi.it
- Recruiting
Azienda Ospedaliero Universitaria di Parma
Parma, PR, 43100
TITO POLI, MD, PhD, +390521703109, tito.poli@unipr.it
Davide Lanfranco, MD, PhD, +390521703109, lanfranco82@yahoo.it
Netherlands2 sites, 1 recruiting
- Active, not recruiting
Stichting VU/VUmc
Amsterdam, 1081 HV
- Recruiting
Maastricht Radiation Oncology MAASTRO Clinic
Maastricht, 6229 ET
Philippe lambin, MD, PhD, +31 88 445 5585, philippe.lambin@maastro.nl
Frank Hoebers, MD, PhD, +31 88 4455666, frank.hoebers@maastro.nl
Germany1 site, 1 recruiting
- Recruiting
Heinrich-Heine Universitaet Dusseldorf, Dept. of Othorinolaryngology, HHU
Düsseldorf, 40225
Kathrin Scheckenbach, MD, PhD, +4981211811 ext. 7570, Scheckenbach@med.uni-duesseldorf.de
Lena Colter, MD, PhD, Lena.Colter@med.uni-duesseldorf.de
About this study
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.
Read the 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.
- Conditions
- Cancer of Head and Neck
- Being tested
- Standard treatment of SCCHN patients
- Keywords
- prognostic modelling, radiomics, clinical decision support system, big data analysis, multiscale prognostic signatures, patient-clinician co-decision tools
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard treatment of SCCHN patientsProcedure or surgery
The interventions may include surgery, radiotherapy, chemotherapy or combined therapies, as recommended by best practice and international guidelines.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Standard treatment of SCCHN patients | |
| 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. Receives: Procedure: Standard treatment of SCCHN patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: through study completion, an average of 3 year
Secondary outcomes (2)
Improved Quality of Life
To measure patients' QoL in relation to the new prognostic stratification
Measured: baseline, month 6, month 18, month 24 after primary treatment
Assess survival time
Overall survival and disease free survival will be assessed to verify the accuracy of the prediction of BD2Decide platform
Measured: at 2, 3 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2019 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cancer of Head and NeckStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 1,450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Parma
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Amsterdam UMC, location VUmc, Heinrich-Heine University, Duesseldorf, Maastricht Radiation Oncology, Istituto Superiore di Sanità
- Responsible party
- Principal investigator, Tito Poli, Azienda Ospedaliero-Universitaria di Parma
- Investigators
- Tito Poli, MD, PHD, Principal investigator, Azienda Ospedaliero-Universitaria di Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02832102
- Sponsor's protocol ID
- H2020-PHC30-689715
- Acronym
- BD2Decide
- Status last verified
- Jul 2016
- First submitted
- 1 Jun 2016
- Last updated
- 14 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patients' data are pseudonymised and stored in a shared Case Report Form (CRF) for data analysis
Publications
Cavalieri S, Brakenhoff RH, Leemans CR, Hoebers FJP, Poli T, Scheckenbach K, Iacovelli NA, Franceschini M, Orlandi E, Licitra L, De Cecco L. Prognostic gene expression signatures for HPV-negative head and neck squamous cell carcinoma. Radiother Oncol. 2025 Jul;208:110900. doi: 10.1016/j.radonc.2025.110900. Epub 2025 Apr 17.
PubMed 40252811Cavalieri 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.
PubMed 34738049
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Big Data and Models for Personalized Head and Neck Cancer Decision Support (BD2Decide)
- ClinicalTrials.gov ID
- NCT02832102
- Acronym / sponsor ID
- BD2Decide / H2020-PHC30-689715
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,450 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria di ParmaUniversity, hospital or other
- Collaborators
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Amsterdam UMC, location VUmc, Heinrich-Heine University, Duesseldorf, Maastricht Radiation Oncology, Istituto Superiore di Sanità
- Study start
- Apr 2016
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 14 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective cohort | – | Procedure: Standard treatment of SCCHN patientsA 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. |
| Prospective cohort | – | Procedure: Standard treatment of SCCHN patientsA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard treatment of SCCHN patientsThe interventions may include surgery, radiotherapy, chemotherapy or combined therapies, as recommended by best practice and international guidelines. | Procedure or surgery | Prospective cohort, Retrospective cohort |
Primary outcome
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).
2 secondary outcomes
Improved Quality of Life
Time frame: baseline, month 6, month 18, month 24 after primary treatment
Assess survival time
Time frame: at 2, 3 and 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2016.
- Derived from this study: PubMed 40252811Cavalieri S, Brakenhoff RH, Leemans CR, Hoebers FJP, Poli T, Scheckenbach K, Iacovelli NA, Franceschini M, Orlandi E, Licitra L, De Cecco L. Prognostic gene expression signatures for HPV-negative head and neck squamous cell carcinoma. Radiother Oncol. 2025 Jul;208:110900. doi: 10.1016/j.radonc.2025.110900. Epub 2025 Apr 17.
- Derived from this study: PubMed 34738049Cavalieri 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.
- Individual participant dataSharing planned: Yes. Patients' data are pseudonymised and stored in a shared Case Report Form (CRF) for data analysis
Related trials for Cancer of Head and Neck
Not yet recruiting
Gut-Liver-Muscle Axis in Cancer Cachexia
Head & Neck Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
Study of XB010 in Subjects With Solid Tumors
Locally Advanced or Metastatic Solid Tumors, Esophageal Squamous Cell Cancer
RecruitingPhase 3
An Imaging Agent (Pafolacianine) for Identifying Lesions in Pediatric Patients With Primary or Metastatic Solid Tumors
Childhood Malignant Solid Neoplasm, Childhood Malignant Thoracic Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tito Poli, MD, PHD principal investigator
Azienda Ospedaliero-Universitaria di Parma
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer of Head and Neck, run by Azienda Ospedaliero-Universitaria di Parma at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy, Netherlands, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tito Poli, MD, PhD (+39052170 ext. 3613, tito.poli@unipr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Realizes and validates an Integrated Decision Support System (BD2Decide platform) (time frame: through study completion, an average of 3 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02832102, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2016; AzTrials last refreshed its copy on 2 Nov 2026.