The Observational Clinical Registry of the European Reference Network on Rare Adult Solid Cancers: the Protocol for the Rare Head and Neck Cancers

Status: Recruiting
Location: See all (11) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Assistance Publique-Hôpitaux de Paris - Hôpital Tenon
NOT_YET_RECRUITING
Paris
Germany
University Hospital Essen
NOT_YET_RECRUITING
Essen
Italy
IRCCS Ospedale Policlinico San Martino
RECRUITING
Genova
Fondazione IRCCS Istituto Nazionale dei Tumori
RECRUITING
Milan
IRCCS Istituto Europeo di Oncologia
RECRUITING
Milan
IRCCS Ospedale San Raffaele
RECRUITING
Milan
Centro Nazionale di Adroterapia Oncologica
RECRUITING
Pavia
Nuovo Ospedale di Prato - S. Stefano
NOT_YET_RECRUITING
Prato
IRCCS Istituto Nazionale Tumori Regina Elena
RECRUITING
Roma
IRCCS Istituto Clinica Humanitas
RECRUITING
Rozzano
Spain
Fundacion Profesor Novoa Santos
NOT_YET_RECRUITING
A Coruña
Contact Information
Primary
Lucia Buratti
EURACANregistry@istitutotumori.mi.it
0223902901
Time Frame
Start Date: 2022-05-31
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 13600
Treatments
epithelial tumours of nasal cavity and paranasal sinus
adult patients diagnosed with nasal cavity and paranasal sinus cancers (any stage of disease)
epithelial tumours of nasopharynx
adult patients diagnosed with nasopharyngeal cancers (any stage of disease)
minor and major salivary gland tumours
adult patients diagnosed with minor or major salivary gland cancers (any stage of disease)
middel ear tumours
adult patients diagnosed with cancers of the middle ear (any stage of disease)
Sponsors
Collaborators: Associazione Italiana Oncologia Cervico Cefalica, European Union, Ministry of Health, Italy, Alleanza Contro il Cancro
Leads: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

This content was sourced from clinicaltrials.gov

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