Protocol ITANET - Registry
Recruiting · NCT04282083 · Observational (researchers observe without assigning treatment) · Lead sponsor: Italian Association Neuroendocrine Tumors
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
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.
Where it is running
37 locations listed.
- 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
- Istituto Nazionale Tumori IRCCS Fondazione G. Pascale - Naples, Italy
- AO Cardarelli - Naples, Italy
- Policlinico Università Federico II - Naples, Italy
- Istituto Oncologico Veneto IRCCS - Padova, 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
- Istituto Clinico Humanitas - Rozzano, Milan, Italy
- Clinica Pederzoli - Peschiera del Garda, Verona, Italy