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

NCT05483374 | Recruiting

• 1 other identifier: INT 43/21
• Study Type: observational
• Target: 13,600
• Locations: 5 countries
• Sites: 12

Brief 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.

Conditions

Head and Neck Cancer; Nasopharynx Cancer; Nasal Cavity and Paranasal Sinus Cancer; Salivary Gland Cancer; Middle Ear Carcinoma

Keywords

Rare cancers; head and neck cancers; registry; protocol

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• Percentage of patients treated according to clinical practice guidelines for head and neck cancer

  Adherence to clinical practice guidelines

  1 year

Study Arms (4)

epithelial tumours of nasal cavity and paranasal sinus

adult patients diagnosed with nasal cavity and paranasal sinus cancers (any stage of disease)

Other: observation

epithelial tumours of nasopharynx

adult patients diagnosed with nasopharyngeal cancers (any stage of disease)

Other: observation

minor and major salivary gland tumours

adult patients diagnosed with minor or major salivary gland cancers (any stage of disease)

Other: observation

middel ear tumours

adult patients diagnosed with cancers of the middle ear (any stage of disease)

Other: observation

Interventions

observation OTHER

Not applicable, it is an observational registry

epithelial tumours of nasal cavity and paranasal sinus; epithelial tumours of nasopharynx; middel ear tumours; minor and major salivary gland tumours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• Patients (aged \< 18 years)

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead
• Associazione Italiana Oncologia Cervico Cefalica: collaborator
• Ministry of Health, Italy: collaborator
• European Union: collaborator
• Alleanza Contro il Cancro: collaborator

Study Sites (12)

Masaryk Memorial Cancer Institute

Brno, Brno, 656 53, Czechia

NOT YET RECRUITING

Assistance Publique-Hôpitaux de Paris - Hôpital Tenon

Paris, Paris, 75020, France

NOT YET RECRUITING

University Hospital Essen

Essen, Hesse, 45147, Germany

NOT YET RECRUITING

IRCCS Ospedale Policlinico San Martino

Genova, Genova, 16132, Italy

RECRUITING

IRCCS Ospedale San Raffaele

Milan, Milano, 20132, Italy

RECRUITING

IRCCS Istituto Europeo di Oncologia

Milan, Milano, 20141, Italy

RECRUITING

IRCCS Istituto Clinica Humanitas

Rozzano, Milano, 20089, Italy

RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Milan, 20133, Italy

RECRUITING

Centro Nazionale di Adroterapia Oncologica

Pavia, Pavia, 27100, Italy

RECRUITING

Nuovo Ospedale di Prato - S. Stefano

Prato, Prato, 59100, Italy

NOT YET RECRUITING

IRCCS Istituto Nazionale Tumori Regina Elena

Roma, Roma, 00144, Italy

RECRUITING

Fundacion Profesor Novoa Santos

A Coruña, A Coruña, 15006, Spain

NOT YET RECRUITING

Related Publications (7)

• 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.

  PMID: 28687376 BACKGROUND

• 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.

  PMID: 29032924 BACKGROUND

• 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.

  PMID: 25131265 BACKGROUND

• 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.

  PMID: 31555591 BACKGROUND

• 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.

  PMID: 29478741 BACKGROUND

• 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/

  PMID: 24945055 BACKGROUND

• Trama A, Licitra L, Cavalieri S, Bonfarnuzzo S, Baili P, Ciarfella A, Parente P, Almadori G, Ansarin M, Bacigalupo A, Baumeister P, Baujat B, Bossi P, Cavalera E, Cercato MC, Dieleman F, Fakhry N, Ferraresi V, Gaino F, Galizia D, Halamkova J, Halme E, Hardillo J, Hofauer B, Kinloch E, Livi L, Locati LD, Mattheis S, Mercante G, Mirabile A, Molteni G, Orlandi E, Persio R, Sciallero S, Smeele L, Tagliabue M, Valentini V, Van Harpen C, Westphalen CB, Botta L. The observational clinical registry (cohort design) of the European Reference Network on Rare Adult Solid Cancers: The protocol for the rare head and neck cancers. PLoS One. 2023 Mar 16;18(3):e0283071. doi: 10.1371/journal.pone.0283071. eCollection 2023.

  PMID: 36928072 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms; Nasopharyngeal Neoplasms; Paranasal Sinus Neoplasms; Salivary Gland Neoplasms

Interventions

Observation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nose Neoplasms; Nose Diseases; Respiratory Tract Diseases; Paranasal Sinus Diseases; Respiratory Tract Neoplasms; Mouth Neoplasms; Mouth Diseases; Salivary Gland Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Annalisa Trama, MD

  Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucia Buratti

CONTACT

0223902901; EURACANregistry@istitutotumori.mi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Epidemiology Valutative Unit

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: August 2, 2022
• Study Start: May 31, 2022
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Starting in June 2022 and ending in January 2030
• Access Criteria: 1. data remain the contributing HCPs or registries property and can't be moved 2. each facility is free to access and use its own data for research 3. each contributing facility can request access to the database adding a SC approved study protocol 4. third parties proposing a research question should work with a EURACAN Principal Investigator (PI) and present a study protocol for SC review 5. each EURACAN domain will define a domain registry working group to review the study protocols 6. once approved, the scientific secretariat will ask the facility to confirm within 2 weeks if it wants to share its data. If it doesn't, it can opt out providing reason. If it doesn't answer, its data will not be used 7. the scientific secretariat will inform the PI of the study about the SC decision 8. the PI will arrange an ethical review that will be shared with the participating centers, which should respond within 60 days 9. International collaboration of the EURACAN Registry is highly supported

Locations

DE (1); IT (8); ES (1); CZ (1); FR (1)