The Head and Neck Registry of the European Reference Network on Rare Adult Solid Cancers

Condition(s) studied

Investigational drug(s) / intervention(s)

observation: Not applicable, it is an observational registry

Study 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

Primary outcome measure(s)

• Overall survival — 1 year
  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
• Disease free survival — 1 year
  The length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer.
• 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. — 1 year
  A change related to treatment
• Incidence of cancer treatment adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) — 1 year
  Any unexpected medical problem that happens during treatment with a drug or other therapy.
• Percentage of patients with surgical complications as assessed by the Clavien-Dindo Classification — 1 year
  Any deviation from the ideal postoperative course that is not inherent in the procedure and does not comprise a failure to cure.
• Percentage of patients treated according to clinical practice guidelines for head and neck cancer — 1 year
  Adherence to clinical practice guidelines

Trial sites (10)

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