The Head and Neck Registry of the European Reference Network on Rare Adult Solid Cancers (EURACAN)
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ClinicalTrials.gov Identifier: NCT05483374 |
Recruitment Status :
Recruiting
First Posted : August 2, 2022
Last Update Posted : April 4, 2024
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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.
Condition or disease | Intervention/treatment |
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Head and Neck Cancer Nasopharynx Cancer Nasal Cavity and Paranasal Sinus Cancer Salivary Gland Cancer Middle Ear Carcinoma | Other: observation |
Study Type : | Observational |
Estimated Enrollment : | 13600 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | The Observational Clinical Registry of the European Reference Network on Rare Adult Solid Cancers: the Protocol for the Rare Head and Neck Cancers |
Actual Study Start Date : | May 31, 2022 |
Estimated Primary Completion Date : | December 31, 2030 |
Estimated Study Completion Date : | December 31, 2030 |
Group/Cohort | Intervention/treatment |
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epithelial tumours of nasal cavity and paranasal sinus
adult patients diagnosed with nasal cavity and paranasal sinus cancers (any stage of disease)
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Other: observation
Not applicable, it is an observational registry |
epithelial tumours of nasopharynx
adult patients diagnosed with nasopharyngeal cancers (any stage of disease)
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Other: observation
Not applicable, it is an observational registry |
minor and major salivary gland tumours
adult patients diagnosed with minor or major salivary gland cancers (any stage of disease)
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Other: observation
Not applicable, it is an observational registry |
middel ear tumours
adult patients diagnosed with cancers of the middle ear (any stage of disease)
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Other: observation
Not applicable, it is an observational registry |
- Overall survival [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 1 year ]A change related to treatment
- Incidence of cancer treatment adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 1 year ]Adherence to clinical practice guidelines
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
It is an hospital based registry thus, hospitals experts in head and neck cancer.
This registry won't select a sample of patients, but it will include every accordant patient present in each facility.
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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05483374
Contact: Lucia Buratti | 0223902901 ext +39 | EURACANregistry@istitutotumori.mi.it |
Czechia | |
Masaryk Memorial Cancer Institute | Not yet recruiting |
Brno, Czechia, 656 53 | |
Contact: Jana Halámková jana.halamkova@mou.cz | |
France | |
Assistance Publique-Hôpitaux de Paris - Hôpital Tenon | Not yet recruiting |
Paris, France, 75020 | |
Contact: Bertrand Baujat 15601641 ext +33 Bertrand.baujat@aphp.fr | |
Germany | |
University Hospital Essen | Not yet recruiting |
Essen, Germany, 45147 | |
Contact: Stefan Mattheis Stefan.Mattheis@uk-essen.de | |
Italy | |
IRCCS Istituto Clinica Humanitas | Recruiting |
Rozzano, Milano, Italy, 20089 | |
Contact: Giuseppe Mercante 02 0224 4602 ext +39 giuseppe.mercante@hunimed.eu | |
IRCCS Ospedale Policlinico San Martino | Recruiting |
Genova, Italy, 16132 | |
Contact: Almalina Bacigalupo almalina.bacigalupo@hsanmartino.it | |
IRCCS Ospedale San Raffaele | Recruiting |
Milano, Italy, 20132 | |
Contact: Aurora Mirabile 02 26 43 60 33 ext +39 mirabile.aurora@hsr.it | |
IRCCS Istituto Europeo di Oncologia | Recruiting |
Milano, Italy, 20141 | |
Contact: Marta Tagliabue 3402835118 ext +39 marta.tagliabue@ieo.it; | |
Fondazione IRCCS Istituto Nazionale dei Tumori | Recruiting |
Milan, Italy, 20133 | |
Contact: Simone Bonfarnuzzo 02 2390 3562 ext +39 simone.bonfarnuzzo@istitutotumori.mi.it | |
Centro Nazionale di Adroterapia Oncologica | Recruiting |
Pavia, Italy, 27100 | |
Contact: Nadia Facchinetti 0382-078 406 ext +39 nadia.facchinetti@cnao.it | |
Nuovo Ospedale di Prato - S. Stefano | Not yet recruiting |
Prato, Italy, 59100 | |
Contact: Giacomo Giulio Baldi giacomogiulio.baldi@uslcentro.toscana.it | |
IRCCS Istituto Nazionale Tumori Regina Elena | Recruiting |
Roma, Italy, 00144 | |
Contact: Valentina Manciocco 06 52664488 ext +39 valentina.manciocco@ifo.it | |
Spain | |
Fundacion Profesor Novoa Santos | Not yet recruiting |
A Coruña, Spain, 15006 | |
Contact: Pablo Parente 639212308 ext +34 plparente@gmail.com |
Principal Investigator: | Annalisa Trama, MD | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano |
Responsible Party: | Annalisa Trama, Head of the Epidemiology Valutative Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano |
ClinicalTrials.gov Identifier: | NCT05483374 |
Other Study ID Numbers: |
INT 43/21 |
First Posted: | August 2, 2022 Key Record Dates |
Last Update Posted: | April 4, 2024 |
Last Verified: | April 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | The governance (link https://euracan.eu/research/starter/european-registry-governance/)set the data access rules to the federated registry |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code |
Time Frame: | Starting in June 2022 and ending in January 2030 |
Access Criteria: |
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URL: | https://euracan.eu/registries/starter/european-registry-governance/ |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Rare cancers head and neck cancers registry protocol |
Head and Neck Neoplasms Salivary Gland Neoplasms Paranasal Sinus Neoplasms Nasopharyngeal Neoplasms Neoplasms by Site Neoplasms Mouth Neoplasms Mouth Diseases Stomatognathic Diseases Salivary Gland Diseases |
Nose Neoplasms Otorhinolaryngologic Neoplasms Nose Diseases Respiratory Tract Diseases Paranasal Sinus Diseases Respiratory Tract Neoplasms Otorhinolaryngologic Diseases Pharyngeal Neoplasms Nasopharyngeal Diseases Pharyngeal Diseases |