Protocol ITANET - Registry

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04282083
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Italian Association Neuroendocrine Tumors
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

MASSIMO FALCONI
Principal Investigator Affiliation San Raffaele Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Italy
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Gastro-entero Pancreatic Neuroendocrine Tumors
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Istituto Clinico Humanitas, Rozzano, Milan, Italy

Status

Recruiting

Address

Istituto Clinico Humanitas

Rozzano, Milan, 20089

Site Contact

Alexia Bertuzzi

[email protected]

0039 02 8224 4599

Clinica Pederzoli, Peschiera Del Garda, Verona, Italy

Status

Recruiting

Address

Clinica Pederzoli

Peschiera Del Garda, Verona,

Site Contact

Giovanni Butturini

[email protected]

+390633775605

AO Ospedali Riuniti, Ancona, Italy

Status

Recruiting

Address

AO Ospedali Riuniti

Ancona, ,

Site Contact

Rossana Berardi

[email protected]

+390633775605

Bari, Italy

Status

Recruiting

Address

Azienda Ospedaliera Universitaria Consorziale Policlinico

Bari, , 70124

Site Contact

Mauro Cives

[email protected]

+390805592859

Bologna, Italy

Status

Recruiting

Address

Azienda Ospedaliera Universitaria Policlinico S. Orsola Malpighi

Bologna, , 40100

Site Contact

Davide Campana

[email protected]

+390512143067

Bologna, Italy

Status

Recruiting

Address

IRCCS Azienda Ospedaliera-Universitaria di Bologna

Bologna, , 40133

Site Contact

Laura Mastrangelo

[email protected]

+393477251184

Ospedale Regionale di Bolzano, Bolzano, Italy

Status

Recruiting

Address

Ospedale Regionale di Bolzano

Bolzano, ,

Site Contact

Michele Ciola

[email protected]

+39 0471 908468

ASST Spedali Civili, Brescia, Italy

Status

Recruiting

Address

ASST Spedali Civili

Brescia, ,

Site Contact

Vito Amoroso

[email protected]

+390633775605

Presidio Ospedaliero A. Perrino, Brindisi, Italy

Status

Recruiting

Address

Presidio Ospedaliero A. Perrino

Brindisi, ,

Site Contact

Saverio Cinieri

[email protected]

+390633775605

Istituto Oncologico del Mediterraneo, Catania, Italy

Status

Recruiting

Address

Istituto Oncologico del Mediterraneo

Catania, ,

Site Contact

Dario Giuffrida

[email protected]

+390633775605

Azienda Ospedaliera Universitaria, Ferrara, Italy

Status

Recruiting

Address

Azienda Ospedaliera Universitaria

Ferrara, ,

Site Contact

Mirco Bartolomei

[email protected]

+390633775605

Ospedale Policlinico S. Martino, Genova, Italy

Status

Recruiting

Address

Ospedale Policlinico S. Martino

Genova, ,

Site Contact

Diego Ferone

[email protected]

+390633775605

Ospedale Santa Maria Goretti, Latina, Italy

Status

Recruiting

Address

Ospedale Santa Maria Goretti

Latina, ,

Site Contact

Chiara Spoto

[email protected]

+390633775605

Messina, Italy

Status

Recruiting

Address

Azienda Ospedaliera Universitaria Policlinico G. Martino

Messina, ,

Site Contact

Sergio Baldari

[email protected]

+390633775605

Istituto Europeo di Oncologia, Milano, Italy

Status

Recruiting

Address

Istituto Europeo di Oncologia

Milano, ,

Site Contact

Emilio Bertani

[email protected]

+390633775605

San Raffaele Hospital, Milan, Italy

Status

Recruiting

Address

San Raffaele Hospital

Milan, , 20132

Site Contact

MASSIMO FALCONI

[email protected]

3397473192

IRCCS Istituto Nazionale Tumori, Milan, Italy

Status

Recruiting

Address

IRCCS Istituto Nazionale Tumori

Milan, , 20133

Site Contact

Filppo De Braud

[email protected]

+390223903066

AOU Policlinico-Modena, Modena, Italy

Status

Recruiting

Address

AOU Policlinico-Modena

Modena, ,

Site Contact

Fabio Gelsomino

[email protected]

+390633775605

Ospedale San Gerardo, Monza, Italy

Status

Recruiting

Address

Ospedale San Gerardo

Monza, ,

Site Contact

Sara Massironi

[email protected]

+390633775605

AO Cardarelli, Naples, Italy

Status

Recruiting

Address

AO Cardarelli

Naples, ,

Site Contact

Ferdinando Riccardi

[email protected]

+390633775605

Napoli, Italy

Status

Recruiting

Address

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

Napoli, , 80131

Site Contact

Salvatore Tafuto

[email protected]

+39 0815903680

Policlinico Università Federico II, Napoli, Italy

Status

Recruiting

Address

Policlinico Università Federico II

Napoli, ,

Site Contact

Annamaria Colao

[email protected]

+390633775605

Istituto Oncologico Veneto IRCCS, Padova, Italy

Status

Recruiting

Address

Istituto Oncologico Veneto IRCCS

Padova, ,

Site Contact

Francesca Bergamo

[email protected]

+390633775605

Palermo, Italy

Status

Recruiting

Address

Centro di Riferimento Regionale per i Tumori Rari dell'adulto Università degli Studi di Palermo

Palermo, ,

Site Contact

Giuseppe Badalamenti

[email protected]

+390633775605

Ospedale Santa Chiara, Pisa, Italy

Status

Recruiting

Address

Ospedale Santa Chiara

Pisa, ,

Site Contact

Riccardo Marconcini

[email protected]

+390633775605

AOUSL-IRCCS-Reggio Emilia, Reggio Emilia, Italy

Status

Recruiting

Address

AOUSL-IRCCS-Reggio Emilia

Reggio Emilia, , 42100

Site Contact

Angelina Filice

[email protected]

+390633775605

Presidio Ospedaliero di Rho, Rho, Italy

Status

Recruiting

Address

Presidio Ospedaliero di Rho

Rho, ,

Site Contact

Roberto Bollina

[email protected]

+390633775605

Istituti Fisioterapici Ospitalieri, Roma, Italy

Status

Recruiting

Address

Istituti Fisioterapici Ospitalieri

Roma, , 00144

Site Contact

Marialuisa Appetecchia

[email protected]

+390652666026

Ospedale San Filippo Neri, Roma, Italy

Status

Recruiting

Address

Ospedale San Filippo Neri

Roma, ,

Site Contact

Domenico Gattuso

[email protected]

+390633775605

Policlinico Umberto I, Roma, Italy

Status

Recruiting

Address

Policlinico Umberto I

Roma, ,

Site Contact

Andrea Isidori

[email protected]

+390633775605

Sant'Andrea Hospital, Rome, Italy

Status

Recruiting

Address

Sant'Andrea Hospital

Rome, , 00189

Site Contact

Francesco Panzuto

[email protected]

+390633775605

Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy

Status

Recruiting

Address

Casa Sollievo della Sofferenza

San Giovanni Rotondo, ,

Site Contact

Maria Grazia Rodriquenz

[email protected]

+390633775605

Azienda Ospedaliera Universitaria, Sassari, Italy

Status

Recruiting

Address

Azienda Ospedaliera Universitaria

Sassari, ,

Site Contact

Giuseppe Fanciulli

[email protected]

+390633775605

Siena, Italy

Status

Recruiting

Address

Center for Immuno-Oncology Medical Oncology and Immunotherapy University of Siena

Siena, ,

Site Contact

Michele Maio

[email protected]

+39 0577 586335

Torino, Italy

Status

Recruiting

Address

Azienda Ospedaliero Universitaria Città della salute e della Scienza

Torino, ,

Site Contact

Emanuela Arvat

[email protected]

+390633775605

Ospedale Santa Chiara, Trento, Italy

Status

Recruiting

Address

Ospedale Santa Chiara

Trento, , 38122

Site Contact

Elettra Merola

[email protected]

+39 0461 903954

Verona, Italy

Status

Recruiting

Address

Azienda Ospedaliera Universitaria integrata

Verona, ,

Site Contact

Luca Landoni

[email protected]

+390633775605

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