Creating a national database for patients with gastro-entero pancreatic neuroendocrine tumors in Italy
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)
This study is creating a national database in Italy to collect information on the diagnosis and treatment of patients with gastro-entero pancreatic neuroendocrine tumors to improve care and follow-up.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Italian Association Neuroendocrine Tumors Research network |
| Locations | 37 sites (Rozzano, Milan and 36 other locations) |
| Trial ID | NCT04282083 on ClinicalTrials.gov |
What this trial studies
This observational study aims to establish a comprehensive Italian database for collecting data on the diagnostic approaches, therapies, and follow-up of patients diagnosed with gastro-entero pancreatic neuroendocrine tumors (GEP-NETs). The project will transfer previously collected data from the ENETS database and continue to gather new data from approximately 200 patients across various participating sites in Italy. Each patient will be pseudonymously identified, and data will be collected both prospectively for new diagnoses and retrospectively for follow-up visits. The study emphasizes patient rights and data management through a structured protocol.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of GEP-NET.
Not a fit: Patients with tumors originating from areas other than the digestive apparatus will not benefit from this study.
Why it matters
Potential benefit: If successful, this initiative could enhance the understanding and treatment of GEP-NETs by providing valuable clinical data.
How similar studies have performed: While this approach builds on previous data collection efforts, it represents a continuation rather than a novel or untested methodology.
Eligibility criteria
Show full 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.
Where this trial is running
Rozzano, Milan and 36 other locations
- Istituto Clinico Humanitas — Rozzano, Milan, Italy (Recruiting)
- Clinica Pederzoli — Peschiera del Garda, Verona, Italy (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)
Study contacts
- Principal investigator: Massimo Falconi — San Raffaele Hospital
- Study coordinator: Francesco Panzuto
- Email: fpanzuto@ospedalesantandrea.it
- Phone: +390633775605
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.