Clinical trial NCT04282083: Protocol ITANET - Registry
Official title: ITANET -Registry: Multicentric Collection of Cases on Neuroendocrin Gastro-Entero-Pancreatic Tumors (Title in Local Language: ITANET -Registry: Raccolta Multicentrica Dei Casi di Tumore Neuroendocrino Gastro-Entero-Pancreatico)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastro-entero Pancreatic Neuroendocrine Tumors
Keywords: GEP-NETs
Lead sponsor: Italian Association Neuroendocrine Tumors
Sponsor class: NETWORK
First posted: 2020-02-24
Enrollment: 3600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients affected by gastro-entero pancreatic neuroendocrine or unknown primary tumor

Brief summary: This is a prospective observational study with the aim to create an Italian database for the collection of data on diagnostic approach, therapy and follow up of patients affected by GEP-NET (gastro-enteric-pancreatic neuroendocrine tumours). Data for approximately 200 italian patients were already previously collected in the ENETS database (international database). ENETS decided to interrupt the collection of the data for an indefinite period. For this reason, through an amendment (number 1) to the protocol, ITANET (Italian Association Neuro-endocrine Tumors) decided to transfer the italian data into a national database and to go on with the collection/update of the data, in order not to lose important clinical information.

Detailed description: Each participating site will have access through the reserved area of webpage https://itanetdb.fullcro.org/, for the data recording in a database which ITANET set-up for the participating sites in Italy.

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.

Eligibility criteria: Inclusion Criteria:

* age\> or = 18 years;
* 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:

* Known tumor origin different from digestive apparatus (GEP NETs);
* 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.

Primary outcomes:
measure: Incidence of GEP-NET in Italy
timeFrame: 3 years
measure: Different localisations of primary GEP-NET
timeFrame: 3 years
measure: Time between symptoms appearance and diagnosis of GEP-NET
timeFrame: 3 years
measure: Type of used and available treatments (medical and surgical)
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milan
city: Peschiera Del Garda
country: Italy
facility: Clinica Pederzoli
state: Verona
city: Ancona
country: Italy
facility: AO Ospedali Riuniti
city: Bari
country: Italy
facility: Azienda Ospedaliera Universitaria Consorziale Policlinico
city: Bologna
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico S. Orsola Malpighi
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliera-Universitaria di Bologna
city: Bolzano
country: Italy
facility: Ospedale Regionale di Bolzano
city: Brescia
country: Italy
facility: ASST Spedali Civili
city: Brindisi
country: Italy
facility: Presidio Ospedaliero A. Perrino
city: Catania
country: Italy
facility: Istituto Oncologico del Mediterraneo
city: Ferrara
country: Italy
facility: Azienda Ospedaliera Universitaria
city: Genova
country: Italy
facility: Ospedale Policlinico S. Martino
city: Latina
country: Italy
facility: Ospedale Santa Maria Goretti
city: Messina
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico G. Martino
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
city: Milan
country: Italy
facility: San Raffaele Hospital
city: Milan
country: Italy
facility: IRCCS Istituto Nazionale Tumori
city: Modena
country: Italy
facility: AOU Policlinico-Modena
city: Monza
country: Italy
facility: Ospedale San Gerardo
city: Naples
country: Italy
facility: AO Cardarelli
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
city: Napoli
country: Italy
facility: Policlinico Università Federico II
city: Padova
country: Italy
facility: Istituto Oncologico Veneto IRCCS
city: Palermo
country: Italy
facility: Centro di Riferimento Regionale per i Tumori Rari dell'adulto Università degli Studi di Palermo
city: Pisa
country: Italy
facility: Ospedale Santa Chiara
city: Reggio Emilia
country: Italy
facility: AOUSL-IRCCS-Reggio Emilia
city: Rho
country: Italy
facility: Presidio Ospedaliero di Rho
city: Roma
country: Italy
facility: Istituti Fisioterapici Ospitalieri
city: Roma
country: Italy
facility: Ospedale San Filippo Neri
city: Roma
country: Italy
facility: Policlinico Umberto I
city: Rome
country: Italy
facility: Sant'Andrea Hospital
city: San Giovanni Rotondo
country: Italy
facility: Casa Sollievo della Sofferenza
city: Sassari
country: Italy
facility: Azienda Ospedaliera Universitaria
city: Siena
country: Italy
facility: Center for Immuno-Oncology Medical Oncology and Immunotherapy University of Siena
city: Torino
country: Italy
facility: Azienda Ospedaliero Universitaria Città della salute e della Scienza
city: Trento
country: Italy
facility: Ospedale Santa Chiara
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria integrata
Study officials:
affiliation: San Raffaele Hospital
name: MASSIMO FALCONI
role: PRINCIPAL_INVESTIGATOR
References: