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Recruiting Observational

Protocol ITANET - Registry

NCT04282083 · tracked via the Priya Life Science Italy tracker
Sponsor
Italian Association Neuroendocrine Tumors
Phase
Observational
Started
2019-05-25
Last updated
2024-01-25

Condition(s) studied

Gastro-entero Pancreatic Neuroendocrine Tumors

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

  • Incidence of GEP-NET in Italy — 3 years
  • Different localisations of primary GEP-NET — 3 years
  • Time between symptoms appearance and diagnosis of GEP-NET — 3 years
  • Type of used and available treatments (medical and surgical) — 3 years

Trial sites (37)

FacilityCityRegionStatus
Istituto Clinico Humanitas Rozzano Milan Recruiting
Clinica Pederzoli Peschiera del Garda Verona Recruiting
AO Ospedali Riuniti Ancona Italy Recruiting
Azienda Ospedaliera Universitaria Consorziale Policlinico Bari Italy Recruiting
Azienda Ospedaliera Universitaria Policlinico S. Orsola Malpighi Bologna Italy Recruiting
IRCCS Azienda Ospedaliera-Universitaria di Bologna Bologna Italy Recruiting
Ospedale Regionale di Bolzano Bolzano Italy Recruiting
ASST Spedali Civili Brescia Italy Recruiting
Presidio Ospedaliero A. Perrino Brindisi Italy Recruiting
Istituto Oncologico del Mediterraneo Catania Italy Recruiting
Azienda Ospedaliera Universitaria Ferrara Italy Recruiting
Ospedale Policlinico S. Martino Genova Italy Recruiting
Ospedale Santa Maria Goretti Latina Italy Recruiting
Azienda Ospedaliera Universitaria Policlinico G. Martino Messina Italy Recruiting
San Raffaele Hospital Milan Italy Recruiting
IRCCS Istituto Nazionale Tumori Milan Italy Recruiting
Istituto Europeo di Oncologia Milan Italy Recruiting
AOU Policlinico-Modena Modena Italy Recruiting
Ospedale San Gerardo Monza Italy Recruiting
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale Naples Italy Recruiting
AO Cardarelli Naples Italy Recruiting
Policlinico Università Federico II Naples Italy Recruiting
Istituto Oncologico Veneto IRCCS Padova Italy Recruiting
Centro di Riferimento Regionale per i Tumori Rari dell'adulto Università degli Studi di Palermo Palermo Italy Recruiting
Ospedale Santa Chiara Pisa Italy Recruiting
AOUSL-IRCCS-Reggio Emilia Reggio Emilia Italy Recruiting
Presidio Ospedaliero di Rho Rho Italy Recruiting
Istituti Fisioterapici Ospitalieri Roma Italy Recruiting
Ospedale San Filippo Neri Roma Italy Recruiting
Policlinico Umberto I Roma Italy Recruiting
Sant'Andrea Hospital Rome Italy Recruiting
Casa Sollievo della Sofferenza San Giovanni Rotondo Italy Recruiting
Azienda Ospedaliera Universitaria Sassari Italy Recruiting
Center for Immuno-Oncology Medical Oncology and Immunotherapy University of Siena Siena Italy Recruiting
Azienda Ospedaliero Universitaria Città della salute e della Scienza Torino Italy Recruiting
Ospedale Santa Chiara Trento Italy Recruiting
Azienda Ospedaliera Universitaria integrata Verona Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04282083 on ClinicalTrials.gov ↗ ← All trials in Italy