Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-03-04 @ 10:40 AM
Study NCT ID:
NCT02832102
Status:
UNKNOWN
Last Update Posted:
2016-07-14
First Post:
2016-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Big Data and Models for Personalized Head and Neck Cancer Decision Support (BD2Decide)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'FFPE tumor specimens'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1450}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2019-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-07-11', 'studyFirstSubmitDate': '2016-06-01', 'studyFirstSubmitQcDate': '2016-07-11', 'lastUpdatePostDateStruct': {'date': '2016-07-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Realizes and validates an Integrated Decision Support System (BD2Decide platform)', 'timeFrame': 'through study completion, an average of 3 year', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Improved Quality of Life', 'timeFrame': 'baseline, month 6, month 18, month 24 after primary treatment', 'description': "To measure patients' QoL in relation to the new prognostic stratification"}, {'measure': 'Assess survival time', 'timeFrame': 'at 2, 3 and 5 years', 'description': 'Overall survival and disease free survival will be assessed to verify the accuracy of the prediction of BD2Decide platform'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['prognostic modelling', 'radiomics', 'clinical decision support system', 'big data analysis', 'multiscale prognostic signatures', 'patient-clinician co-decision tools'], 'conditions': ['Cancer of Head and Neck']}, 'referencesModule': {'references': [{'pmid': '40252811', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '34738049', 'type': 'DERIVED', 'citation': 'Cavalieri 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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'The clinical study is devoted to the validation of a decision support system for HNC patients management in the frame of a H2020 project.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Prospective study cohort: A total of 450 SCCHN patients Stage III and IV, followed up for 18-24 months or more.\n\nRetrospective study cohort: A total of 1000 SCCHN patients Stage III and IV, diagnosed between year 2008 and 2014.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent\n* Histologically confirmed diagnosis of oral cavity, oropharynx, larynx, hypopharynx squamous cell carcinoma\n* Clinical stage III and IV\n* Patient candidate for curative treatment: ± surgery ± radiotherapy ± chemotherapy\n* Adequate archival pre-treatment tumor specimen available (FFPE macrodissected sections)\n* 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.\n* 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\n* Male or female ≥ 18 years old\n\nExclusion Criteria:\n\n* Any previous haed and neck cancer.\n* 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.\n* Any previous malignancy that was treated with surgery and or radiation of the head and neck region.\n* Histological type other than head and neck squamous cell cancer (nasopharynx, salivary glands and sinus nasal cancer are excluded).'}, 'identificationModule': {'nctId': 'NCT02832102', 'acronym': 'BD2Decide', 'briefTitle': 'Big Data and Models for Personalized Head and Neck Cancer Decision Support (BD2Decide)', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliero-Universitaria di Parma'}, 'officialTitle': 'Big Data and Models for Personalized Head and Neck Cancer Decision Support (BD2Decide)', 'orgStudyIdInfo': {'id': 'H2020-PHC30-689715'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Retrospective cohort', 'description': 'A total of 1000 SCCHN patients will be enrolled in a retrospective observational study treated in the period 2008-2014.\n\nStandard 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.\n\nStandard treatment of SCCHN patients: patients will be administered current best clinical practice treatments.', 'interventionNames': ['Procedure: Standard treatment of SCCHN patients']}], 'interventions': [{'name': 'Standard treatment of SCCHN patients', 'type': 'PROCEDURE', 'description': 'The interventions may include surgery, radiotherapy, chemotherapy or combined therapies, as recommended by best practice and international guidelines.', 'armGroupLabels': ['Prospective cohort', 'Retrospective cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40225', 'city': 'Düsseldorf', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Kathrin Scheckenbach, MD, PhD', 'role': 'CONTACT', 'email': 'Scheckenbach@med.uni-duesseldorf.de', 'phone': '+4981211811', 'phoneExt': '7570'}, {'name': 'Lena Colter, MD, PhD', 'role': 'CONTACT', 'email': 'Lena.Colter@med.uni-duesseldorf.de'}, {'name': 'Kathrin Scheckenbach, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jörg Schipper, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Lena Colter, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Heinrich-Heine Universitaet Dusseldorf, Dept. of Othorinolaryngology, HHU', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '20133', 'city': 'Milan', 'state': 'MI', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'LISA LICITRA, MD, PhD', 'role': 'CONTACT', 'email': 'lisa.licitra@istitutotumori.mi.it', 'phone': '+39 022390', 'phoneExt': '2150'}, {'name': 'Federica Favales', 'role': 'CONTACT', 'email': 'federica.favales@istitutotumori.mi.it', 'phone': '+39 022390', 'phoneExt': '3287'}, {'name': 'Lisa Licitra, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Gemma Gatta, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Federica Favales, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Annalisa Trama, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Loris De Cecco, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Fondazione Irccs Istituto Dei Tumori Milano', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '43100', 'city': 'Parma', 'state': 'PR', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'TITO POLI, MD, PhD', 'role': 'CONTACT', 'email': 'tito.poli@unipr.it', 'phone': '+390521703109'}, {'name': 'Davide Lanfranco, MD, PhD', 'role': 'CONTACT', 'email': 'lanfranco82@yahoo.it', 'phone': '+390521703109'}, {'name': 'Enrico M Silini, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tito Poli, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Giuseppe Maglietta, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Caterina Caminiti, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliero Universitaria di Parma', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}, {'zip': '1081 HV', 'city': 'Amsterdam', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Netherlands', 'facility': 'Stichting VU/VUmc', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '6229 ET', 'city': 'Maastricht', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Philippe lambin, MD, PhD', 'role': 'CONTACT', 'email': 'philippe.lambin@maastro.nl', 'phone': '+31 88 445 5585'}, {'name': 'Frank Hoebers, MD, PhD', 'role': 'CONTACT', 'email': 'frank.hoebers@maastro.nl', 'phone': '+31 88 4455666'}, {'name': 'Philippe lambin, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Frank Hoebers, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Adriana Berlanga, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Maastricht Radiation Oncology MAASTRO Clinic', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'centralContacts': [{'name': 'Tito Poli, MD, PhD', 'role': 'CONTACT', 'email': 'tito.poli@unipr.it', 'phone': '+39052170', 'phoneExt': '3613'}, {'name': 'Lisa Licitra, MD, PhD', 'role': 'CONTACT', 'email': 'lisa.licitra@istitutotumori.mi.it', 'phone': '+39 022390', 'phoneExt': '2150'}], 'overallOfficials': [{'name': 'Tito Poli, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Azienda Ospedaliero-Universitaria di Parma'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Patients' data are pseudonymised and stored in a shared Case Report Form (CRF) for data analysis"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliero-Universitaria di Parma', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milano', 'class': 'OTHER'}, {'name': 'Amsterdam UMC, location VUmc', 'class': 'OTHER'}, {'name': 'Heinrich-Heine University, Duesseldorf', 'class': 'OTHER'}, {'name': 'Maastricht Radiation Oncology', 'class': 'OTHER'}, {'name': 'Istituto Superiore di Sanità', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Tito Poli', 'investigatorAffiliation': 'Azienda Ospedaliero-Universitaria di Parma'}}}}