Clinical trial · Observational
Big Data and Models for Personalized Head and Neck Cancer Decision Support (BD2Decide)
NCT02832102CI-TRIAL-00023076BD2DecideunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Head and Neck | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard treatment of SCCHN patients | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- 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.
- interventionNames
- Procedure: Standard treatment of SCCHN patients
- label
- 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.
- interventionNames
- Procedure: Standard treatment of SCCHN patients
Primary outcomes (1)
- measure
- Realizes and validates an Integrated Decision Support System (BD2Decide platform)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (2)
- DERIVEDCavalieri 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. PMID 40252811
- DERIVEDCavalieri 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. PMID 34738049