Gastro-entero Pancreatic Neuroendocrine TumorsNCT04282083
Protocol ITANET - Registry
An observational study of Gastro-entero Pancreatic Neuroendocrine Tumors, run by Italian Association Neuroendocrine Tumors at 37 sites in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastro-entero Pancreatic Neuroendocrine Tumors
- How many people
- 3,600 participants
- Where
- 37 sitesItaly
- Study dates
- 25 May 2019to 31 Jul 2032
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients affected by gastro-entero pancreatic neuroendocrine or unknown primary tumor
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
37 sites in 1 country. Contact the study team or a site near you to ask about taking part.
37 sites in 1 country
Italy37 sites, 37 recruiting
- Recruiting
AO Ospedali Riuniti
Ancona
Rossana Berardi, rossana.berardi@ospedaliriuniti.marche.it
- Recruiting
Azienda Ospedaliera Universitaria Consorziale Policlinico
Bari, 70124
Mauro Cives, +390805592859, mauro.cives@uniba.it
Anna Ragno, +390805592759, ragnoanna@tiscali.it
- Recruiting
Azienda Ospedaliera Universitaria Policlinico S. Orsola Malpighi
Bologna, 40100
Davide Campana, +390512143067, davide.campana@unibo.it
Giuseppe Lamberti, +390512143067, giuseppe.lamberti8@unibo.it
- Recruiting
IRCCS Azienda Ospedaliera-Universitaria di Bologna
Bologna, 40133
Laura Mastrangelo, +393477251184, laura.mastrangelo@ausl.bologna.it
Elio Jovine, +393386468200, elio.jovine@ausl.bologna.it
- Recruiting
Ospedale Regionale di Bolzano
Bolzano
Michele Ciola, +39 0471 908468, michele.ciola@sabes.it
- Recruiting
ASST Spedali Civili
Brescia
Vito Amoroso, vitoamoroso@alice.it
- Recruiting
Presidio Ospedaliero A. Perrino
Brindisi
Saverio Cinieri, saverio.cinieri@gmail.com
- Recruiting
Istituto Oncologico del Mediterraneo
Catania
Dario Giuffrida, dario.giuffrida@grupposamed.com
- Recruiting
Azienda Ospedaliera Universitaria
Ferrara
Mirco Bartolomei, m.bartolomei@ospfe.it
- Recruiting
Ospedale Policlinico S. Martino
Genova
Diego Ferone
- Recruiting
Ospedale Santa Maria Goretti
Latina
Chiara Spoto, c.spoto@ausl.latina.it
- Recruiting
Azienda Ospedaliera Universitaria Policlinico G. Martino
Messina
Sergio Baldari, sbaldari@unime.it
- Recruiting
San Raffaele Hospital
Milan, 20132
MASSIMO FALCONI, 3397473192, falconi.massimo@hsr.it
- Recruiting
IRCCS Istituto Nazionale Tumori
Milan, 20133
Filppo De Braud, +390223903066, Filippo.DeBraud@istitutotumori.mi.it
- Recruiting
Istituto Europeo di Oncologia
Milan
Emilio Bertani, emilio.bertani@ieo.it
- Recruiting
AOU Policlinico-Modena
Modena
Fabio Gelsomino, gelsomino.fabio@aou.mo.it
- Recruiting
Ospedale San Gerardo
Monza
Sara Massironi, s.massironi@asst-monza.it
- Recruiting
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Naples, 80131
Salvatore Tafuto, +39 0815903680, s.tafuto@istitutotumori.na.it
- Recruiting
AO Cardarelli
Naples
Ferdinando Riccardi, ferdinando.riccardi@aocardarelli.it
- Recruiting
Policlinico Università Federico II
Naples
Annamaria Colao, colao@unina.it
- Recruiting
Istituto Oncologico Veneto IRCCS
Padova
Francesca Bergamo, francesca.bergamo@iov.veneto.it
- Recruiting
Centro di Riferimento Regionale per i Tumori Rari dell'adulto Università degli Studi di Palermo
Palermo
Giuseppe Badalamenti, giuseppe.badalamenti@unipa.it
- Recruiting
Clinica Pederzoli
Peschiera del Garda, Verona
Giovanni Butturini, butturinichirurgo@gmail.com
- Recruiting
Ospedale Santa Chiara
Pisa
Riccardo Marconcini, marconcini.riccardo@gmail.com
- Recruiting
AOUSL-IRCCS-Reggio Emilia
Reggio Emilia, 42100
Angelina Filice, Angelina.Filice@ausl.re.it
- Recruiting
Presidio Ospedaliero di Rho
Rho
Roberto Bollina, rbollina@asst-rhodense.it
- Recruiting
Istituti Fisioterapici Ospitalieri
Roma, 00144
Marialuisa Appetecchia, +390652666026, marialuisa.appetecchia@ifo.gov.it
Giulia Puliani, +393400575162, giulia.puliani@ifo.gov.it
- Recruiting
Ospedale San Filippo Neri
Roma
Domenico Gattuso, domenico.gattuso@aslroma1.it
- Recruiting
Policlinico Umberto I
Roma
Andrea Isidori, andrea.isidori@uniroma1.it
- Recruiting
Sant'Andrea Hospital
Rome, 00189
Francesco Panzuto, +390633775605, fpanzuto@ospedalesantandrea.it
Maria Rinzivillo, +390633775605, mrinzivillo@ospedalesantandrea.it
- Recruiting
Istituto Clinico Humanitas
Rozzano, Milan, 20089
Alexia Bertuzzi, 0039 02 8224 4599, alexia.bertuzzi@cancercenter.humanitas.it
- Recruiting
Casa Sollievo della Sofferenza
San Giovanni Rotondo
Maria Grazia Rodriquenz, grazia.rodriquenz@gmail.com
- Recruiting
Azienda Ospedaliera Universitaria
Sassari
Giuseppe Fanciulli, gfanciu@uniss.it
- Recruiting
Center for Immuno-Oncology Medical Oncology and Immunotherapy University of Siena
Siena
Michele Maio, +39 0577 586335, mmaiocro@gmail.com
- Recruiting
Azienda Ospedaliero Universitaria Città della salute e della Scienza
Torino
Emanuela Arvat, emanuela.arvat@unito.it
- Recruiting
Ospedale Santa Chiara
Trento, 38122
Elettra Merola, +39 0461 903954, elettra.merola@apss.tn.it
- Recruiting
Azienda Ospedaliera Universitaria integrata
Verona
Luca Landoni, luca.landoni@aovr.veneto.it
About this study
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)
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.
Read the 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:
- The data are acceptable: in this case the data will be validated;
- 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.
- Keywords
- GEP-NETs
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of GEP-NET in Italy
Measured: 3 years
Different localisations of primary GEP-NET
Measured: 3 years
Time between symptoms appearance and diagnosis of GEP-NET
Measured: 3 years
Type of used and available treatments (medical and surgical)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start25 May 2019
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastro-entero Pancreatic Neuroendocrine TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 3,600 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Italian Association Neuroendocrine Tumors
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- MASSIMO FALCONI, Principal investigator, San Raffaele Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282083
- Sponsor's protocol ID
- 001
- Status last verified
- Jan 2024
- First submitted
- 3 Feb 2020
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Panzuto F, Partelli S, Campana D, de Braud F, Spada F, Cives M, Tafuto S, Bertuzzi A, Gelsomino F, Bergamo F, Marcucci S, Mastrangelo L, Massironi S, Appetecchia M, Filice A, Badalamenti G, Bartolomei M, Amoroso V, Landoni L, Rodriquenz MG, Valente M, Colao A, Isidori A, Fanciulli G, Bollina R, Ciola M, Butturini G, Marconcini R, Arvat E, Cinieri S, Berardi R, Baldari S, Riccardi F, Spoto C, Giuffrida D, Gattuso D, Ferone D, Rinzivillo M, Bertani E, Versari A, Zerbi A, Lamberti G, Lauricella E, Pusceddu S, Fazio N, Dell'Unto E, Marini M, Falconi M. Epidemiology of gastroenteropancreatic neuroendocrine neoplasms: a review and protocol presentation for bridging tumor registry data with the Italian association for neuroendocrine tumors (Itanet) national database. Endocrine. 2024 Apr;84(1):42-47. doi: 10.1007/s12020-023-03649-4. Epub 2024 Jan 4.
PubMed 38175391
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04282083
- Acronym / sponsor ID
- 001
- Keywords
- GEP-NETs
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,600 participants (estimated)
- Lead sponsor
- Italian Association Neuroendocrine TumorsResearch network
- Study start
- 25 May 2019 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2032 (estimated)
- First posted
- 24 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- The data are acceptable: in this case the data will be validated;
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by gastro-entero pancreatic neuroendocrine or unknown primary tumor
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of GEP-NET in Italy
Time frame: 3 years
Different localisations of primary GEP-NET
Time frame: 3 years
Time between symptoms appearance and diagnosis of GEP-NET
Time frame: 3 years
Type of used and available treatments (medical and surgical)
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Derived from this study: PubMed 38175391Panzuto F, Partelli S, Campana D, de Braud F, Spada F, Cives M, Tafuto S, Bertuzzi A, Gelsomino F, Bergamo F, Marcucci S, Mastrangelo L, Massironi S, Appetecchia M, Filice A, Badalamenti G, Bartolomei M, Amoroso V, Landoni L, Rodriquenz MG, Valente M, Colao A, Isidori A, Fanciulli G, Bollina R, Ciola M, Butturini G, Marconcini R, Arvat E, Cinieri S, Berardi R, Baldari S, Riccardi F, Spoto C, Giuffrida D, Gattuso D, Ferone D, Rinzivillo M, Bertani E, Versari A, Zerbi A, Lamberti G, Lauricella E, Pusceddu S, Fazio N, Dell'Unto E, Marini M, Falconi M. Epidemiology of gastroenteropancreatic neuroendocrine neoplasms: a review and protocol presentation for bridging tumor registry data with the Italian association for neuroendocrine tumors (Itanet) national database. Endocrine. 2024 Apr;84(1):42-47. doi: 10.1007/s12020-023-03649-4. Epub 2024 Jan 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
MASSIMO FALCONI principal investigator
San Raffaele Hospital
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastro-entero Pancreatic Neuroendocrine Tumors, run by Italian Association Neuroendocrine Tumors at 37 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesco Panzuto (+390633775605, fpanzuto@ospedalesantandrea.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of GEP-NET in Italy (time frame: 3 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04282083, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2024.