Study Results
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Basic Information
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RECRUITING
3600 participants
OBSERVATIONAL
2019-05-25
2032-07-31
Brief Summary
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Detailed Description
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The eligible patients, visited at each participating site, will be asked to adhere to the ITANET-project through a proper Informed Consent obtainment procedure.
Adequate procedures are described in the protocol amendment 1 (and in a proper Standard Operating Procedure) also for the management of the already collected data in the previous ENETS registry whose transferral/update/deletion in the ITANET database are well defined and regulated in order to respect and preserve the patients' rights.
The data will be collected in an pseudo-anonymised way. Each patient will be identified by a code.
The data management and quality check of the Italian data is deputed to ITANET. The data will be collected in a prospective way, both for the new diagnoses (first visits) and for the follow up visits of patients with already acquired diagnosis. For the patients with already acquired diagnosis, these diagnostic data can be collected retrospectively, but not earlier than 1 year from the date of informed consent signature.The enrolment will take place during the outpatient visit or at the time of the hospitalisation for the NET-related surgery.
Of course, considering the observational nature of the study, the follow up visits will be planned on the basis of each patient's clinical need, which is different patient by patient, according to the disease staging, the primary tumour location, the eventual surgery.
The data flow will be the following:
* The participating site records the data in the database, waiting to be validated;
* ITANET has the role to check the recorded data for completeness and coherence in order to decide whether:
1. The data are acceptable: in this case the data will be validated;
2. There are discrepancies: in this case a query will be sent to the related site in order to check, correct/explain where applicable and to resubmit the data. The process starts again until final validation.
The data will be collected yearly to provide several information, such as:
* Type of NETs followed by the reference national sites for the management of the study pathology;
* Tools used for the diagnosis definition and the disease staging;
* Therapeutic approach (surgical or medical);
* Disease trend during follow up.
Conditions
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Study Design
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COHORT
OTHER
Eligibility Criteria
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Inclusion Criteria
* histologically/cytologically proved diagnosis of NET OR diagnosis supported by a PET Gallium 68 positivity and by at least a contrastografic imaging of second level (CT scan or NMR);
* Diagnosis of GEP-NET not antecedent 1 year since the Informed Consent signature;
* Grading G1, G2, G3 according to the classification WHO 2019;
* Tumor origin in digestive apparatus (GEP NETs) or tumor of unknown origin;
* Signed Informed consent.
Exclusion Criteria
* no evidence of histologically/cytologically proved diagnosis of NET OR diagnosis supported by a PET Gallium 68 positivity and by at least a contrastografic imaging of second level (CT scan or NMR);
* Diagnosis of GEP-NET antecedent 1 year since the Informed Consent signature.
18 Years
ALL
No
Sponsors
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Italian Association Neuroendocrine Tumors
NETWORK
Responsible Party
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Principal Investigators
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MASSIMO FALCONI
Role: PRINCIPAL_INVESTIGATOR
San Raffaele Hospital
Locations
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Istituto Clinico Humanitas
Rozzano, Milan, Italy
Clinica Pederzoli
Peschiera del Garda, Verona, Italy
AO Ospedali Riuniti
Ancona, , Italy
Azienda Ospedaliera Universitaria Consorziale Policlinico
Bari, , Italy
Azienda Ospedaliera Universitaria Policlinico S. Orsola Malpighi
Bologna, , Italy
IRCCS Azienda Ospedaliera-Universitaria di Bologna
Bologna, , Italy
Ospedale Regionale di Bolzano
Bolzano, , Italy
ASST Spedali Civili
Brescia, , Italy
Presidio Ospedaliero A. Perrino
Brindisi, , Italy
Istituto Oncologico del Mediterraneo
Catania, , Italy
Azienda Ospedaliera Universitaria
Ferrara, , Italy
Ospedale Policlinico S. Martino
Genova, , Italy
Ospedale Santa Maria Goretti
Latina, , Italy
Azienda Ospedaliera Universitaria Policlinico G. Martino
Messina, , Italy
San Raffaele Hospital
Milan, , Italy
IRCCS Istituto Nazionale Tumori
Milan, , Italy
Istituto Europeo di Oncologia
Milan, , Italy
AOU Policlinico-Modena
Modena, , Italy
Ospedale San Gerardo
Monza, , Italy
AO Cardarelli
Naples, , Italy
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Napoli, , Italy
Policlinico Università Federico II
Napoli, , Italy
Istituto Oncologico Veneto IRCCS
Padua, , Italy
Centro di Riferimento Regionale per i Tumori Rari dell'adulto Università degli Studi di Palermo
Palermo, , Italy
Ospedale Santa Chiara
Pisa, , Italy
AOUSL-IRCCS-Reggio Emilia
Reggio Emilia, , Italy
Presidio Ospedaliero di Rho
Rho, , Italy
Istituti Fisioterapici Ospitalieri
Roma, , Italy
Ospedale San Filippo Neri
Roma, , Italy
Policlinico Umberto I
Roma, , Italy
Sant'Andrea Hospital
Rome, , Italy
Casa Sollievo della Sofferenza
San Giovanni Rotondo, , Italy
Azienda Ospedaliera Universitaria
Sassari, , Italy
Center for Immuno-Oncology Medical Oncology and Immunotherapy University of Siena
Siena, , Italy
Azienda Ospedaliero Universitaria Città della salute e della Scienza
Torino, , Italy
Ospedale Santa Chiara
Trento, , Italy
Azienda Ospedaliera Universitaria integrata
Verona, , Italy
Countries
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Central Contacts
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Facility Contacts
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Diego Ferone
Role: primary
References
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Panzuto F, Partelli S, Campana D, de Braud F, Spada F, Cives M, Tafuto S, Bertuzzi A, Gelsomino F, Bergamo F, Marcucci S, Mastrangelo L, Massironi S, Appetecchia M, Filice A, Badalamenti G, Bartolomei M, Amoroso V, Landoni L, Rodriquenz MG, Valente M, Colao A, Isidori A, Fanciulli G, Bollina R, Ciola M, Butturini G, Marconcini R, Arvat E, Cinieri S, Berardi R, Baldari S, Riccardi F, Spoto C, Giuffrida D, Gattuso D, Ferone D, Rinzivillo M, Bertani E, Versari A, Zerbi A, Lamberti G, Lauricella E, Pusceddu S, Fazio N, Dell'Unto E, Marini M, Falconi M. Epidemiology of gastroenteropancreatic neuroendocrine neoplasms: a review and protocol presentation for bridging tumor registry data with the Italian association for neuroendocrine tumors (Itanet) national database. Endocrine. 2024 Apr;84(1):42-47. doi: 10.1007/s12020-023-03649-4. Epub 2024 Jan 4.
Other Identifiers
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001
Identifier Type: -
Identifier Source: org_study_id
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