Head and Neck Cancer Clinical Trial
— EURACANOfficial title:
The Observational Clinical Registry of the European Reference Network on Rare Adult Solid Cancers: the Protocol for the Rare Head and Neck Cancers
NCT number | NCT05483374 |
Other study ID # | INT 43/21 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 31, 2022 |
Est. completion date | December 31, 2030 |
Cancer care for head and neck cancers is multidisciplinary and complex and knowledge on the rare ones is limited. There is a wide consensus that to support clinical research on rare cancers, clinical registries should be developed within networks specializing in rare cancers. Our hypothesis is that our head and neck cancer registry established in the framework of the European reference network on rare adults solid cancers will help to: describe the natural history of rare head and neck cancers; evaluate factors that influence prognosis; assess treatment effectiveness; measure indicators of quality of care. The registry is a prospective observational real-world registry. It collects data from already available registries/database and/or directly from expert health care providers (HCP). Information are prospectively collected on patient characteristics; exposure, outcomes and potential confounders (https://euracan.eu/research/starter/rare-head-and-neck-cancer-registry/#codebook). The registry if federated (i.e. data are stored by the data provider). Analyses will be performed using the federated learning approach which split computations into a local part and a central part. The data providers will share sub-computations only. Data quality checks are envisioned to assess whether data value are present, valid and believable. Validity and plausibility checks are embedded in the electronic case report form (CRF) in the form of alerts and errors during the data input. Additional checks are implemented in R and run using the federated learning to ensure a central data quality monitoring. The data analyses will include descriptive statistics showing frequency and patterns of patients' and cancers' variables; analytical analyses investigating the association of patients/disease and/or treatment characteristics and health outcomes. Fondazione IRCCS Istituto Nazionale dei Tumori (INT) is the coordinator of the EURACAN registry as well as a data provider. At the INT, and at each HCP involved, responsible investigators ensure that the EURACAN registry will be implemented in compliance with the protocol, following the instructions and procedures described herein. Each HCP is a controller and will identify a data processor. The processing of patients' personal data taking part in the registry is compliant with local privacy legislation and the General Data Protection Regulation 2016/679 of the EU.
Status | Recruiting |
Enrollment | 13600 |
Est. completion date | December 31, 2030 |
Est. primary completion date | December 31, 2030 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients with epithelial tumours of nasopharynx; nasal cavity and paranasal sinuses; salivary gland cancer in large and small salivary glands; and middle ear (i.e. squamous carcinoma; adenocarcinoma; neuroendocrine; adenosquamous carcinoma, teratocarcinosarcoma, NUT carcinoma, odontogenic tumors) + neuroendocrine and adenocarcinoma in hypopharynx; oropharynx; larynx; oral cavity and lip + odontogenic carcinoma in oral cavity. - Adult patients (aged =18 years). - Diagnosis performed or verified by the expert centre entering the patient information in the registry. - Patients entering the HCP at any clinical phase of the disease (diagnosis, treatment of primary cancer, treatment of recurrence, treatment of M+ etc.). The HCP can decide, based on its resources, the number of patients on whom it can collect data. - New patients managed by the HCP from 2021 onwards plus patients managed by the HCP, who are actively followed up at the hospital, with year of diagnosis dating back to maximum 2018. Exclusion Criteria: • Patients (aged < 18 years) |
Country | Name | City | State |
---|---|---|---|
Czechia | Masaryk Memorial Cancer Institute | Brno | |
France | Assistance Publique-Hôpitaux de Paris - Hôpital Tenon | Paris | |
Germany | University Hospital Essen | Essen | |
Italy | IRCCS Ospedale Policlinico San Martino | Genova | |
Italy | Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | |
Italy | IRCCS Istituto Europeo di Oncologia | Milano | |
Italy | IRCCS Ospedale San Raffaele | Milano | |
Italy | Centro Nazionale di Adroterapia Oncologica | Pavia | |
Italy | Nuovo Ospedale di Prato - S. Stefano | Prato | |
Italy | IRCCS Istituto Nazionale Tumori Regina Elena | Roma | |
Italy | IRCCS Istituto Clinica Humanitas | Rozzano | Milano |
Spain | Fundacion Profesor Novoa Santos | A Coruña |
Lead Sponsor | Collaborator |
---|---|
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | Alleanza Contro il Cancro, Associazione Italiana Oncologia Cervico Cefalica, European Union, Ministry of Health, Italy |
Czechia, France, Germany, Italy, Spain,
Gatta G, Capocaccia R, Botta L, Mallone S, De Angelis R, Ardanaz E, Comber H, Dimitrova N, Leinonen MK, Siesling S, van der Zwan JM, Van Eycken L, Visser O, Zakelj MP, Anderson LA, Bella F, Kaire I, Otter R, Stiller CA, Trama A; RARECAREnet working group. Burden and centralised treatment in Europe of rare tumours: results of RARECAREnet-a population-based study. Lancet Oncol. 2017 Aug;18(8):1022-1039. doi: 10.1016/S1470-2045(17)30445-X. Epub 2017 Jul 4. Erratum In: Lancet Oncol. 2017 Aug;18(8):e433. — View Citation
Gatta G, Trama A, Capocaccia R; RARECARENet Working Group. Epidemiology of rare cancers and inequalities in oncologic outcomes. Eur J Surg Oncol. 2019 Jan;45(1):3-11. doi: 10.1016/j.ejso.2017.08.018. Epub 2017 Sep 19. — View Citation
Gliklich RE, Dreyer NA, Leavy MB, editors. Registries for Evaluating Patient Outcomes: A User's Guide [Internet]. 3rd edition. Rockville (MD): Agency for Healthcare Research and Quality (US); 2014 Apr. Report No.: 13(14)-EHC111. Available from http://www.ncbi.nlm.nih.gov/books/NBK208616/ — View Citation
Orlandi E, Alfieri S, Simon C, Trama A, Licitra L; RARECAREnet Working Group. Treatment challenges in and outside a network setting: Head and neck cancers. Eur J Surg Oncol. 2019 Jan;45(1):40-45. doi: 10.1016/j.ejso.2018.02.007. Epub 2018 Feb 14. — View Citation
Siesling S, Louwman WJ, Kwast A, van den Hurk C, O'Callaghan M, Rosso S, Zanetti R, Storm H, Comber H, Steliarova-Foucher E, Coebergh JW. Uses of cancer registries for public health and clinical research in Europe: Results of the European Network of Cancer Registries survey among 161 population-based cancer registries during 2010-2012. Eur J Cancer. 2015 Jun;51(9):1039-49. doi: 10.1016/j.ejca.2014.07.016. Epub 2014 Aug 15. — View Citation
Trama A, Botta L, Foschi R, Visser O, Borras JM, Zagar T, Primic-Zakelj M, Bella F, Dimitrova N, Gatta G, Licitra L. Quality of Care Indicators for Head and Neck Cancers: The Experience of the European Project RARECAREnet. Front Oncol. 2019 Aug 28;9:837. doi: 10.3389/fonc.2019.00837. eCollection 2019. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival | The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive | 1 year | |
Primary | Disease free survival | The length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer. | 1 year | |
Primary | The percentage of patients whose cancer shrinks or disappears after treatment. Treatment response expressed as a complete response; partial response; stable disease; progression based on clinical judgment on imaging. | A change related to treatment | 1 year | |
Primary | Incidence of cancer treatment adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) | Any unexpected medical problem that happens during treatment with a drug or other therapy. | 1 year | |
Primary | Percentage of patients with surgical complications as assessed by the Clavien-Dindo Classification | Any deviation from the ideal postoperative course that is not inherent in the procedure and does not comprise a failure to cure. | 1 year | |
Primary | Percentage of patients treated according to clinical practice guidelines for head and neck cancer | Adherence to clinical practice guidelines | 1 year |
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