Indikation (Clinical Trials):
Head and Neck Neoplasms
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
-
Sponsor:
Azienda Ospedaliero-Universitaria di Parma
Collaborator:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, VU University Medical Center, Heinrich-Heine University, Duesseldorf, Maastricht Radiation Oncology, Istituto Superiore di Sanità,
Studienleiter
Tito Poli, MD, PHD Principal Investigator Azienda Ospedaliero-Universitaria di Parma
- 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).
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:
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
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.
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.
Standard treatment of SCCHN patients: The interventions may include surgery, radiotherapy, chemotherapy or combined therapies, as recommended by best practice and international guidelines.
Quelle: ClinicalTrials.gov
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"Big Data and Models for Personalized Head and Neck Cancer Decision Support (BD2Decide)"
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