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Database ITANET - ENETS Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04282083
Recruitment Status : Recruiting
First Posted : February 24, 2020
Last Update Posted : April 27, 2020
Sponsor:
Information provided by (Responsible Party):
Italian Association Neuroendocrine Tumors

Brief 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) and to include these data into a multi-national European registry database, adhering to the ENETS (european neuroendocrine tumor society)-registry project.

Condition or disease
Gastro-entero Pancreatic Neuroendocrine Tumors

Detailed Description:

Each participating site will have access through the reserved area of webpage www.ita-net.org, where a proper link is enabled for the data recording in a database which ENETS set-up for the participating Sites in Europe, the ENETS-registry (https://www.enets-registry.eu/enets/).

The eligible patients, visited at each participating site, will be asked to adhere to the ENETS-project through a proper Informed Consent obtainment procedure.

The data will be collected in an 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. 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 validated data will be acquired from ENETS-registry;
    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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3600 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Database ITANET (Italian Neuroendocrine Tumors Association) - ENETS Registry
Actual Study Start Date : May 25, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2022





Primary Outcome Measures :
  1. Incidence of GEP-NET in Italy [ Time Frame: 3 years ]
  2. Different localisations of primary GEP-NET [ Time Frame: 3 years ]
  3. Time between symptoms appearance and diagnosis of GEP-NET [ Time Frame: 3 years ]
  4. Type of used and available treatments (medical and surgical) [ Time Frame: 3 years ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients affected by gastro-entero pancreatic neuroendocrine or unknown primary tumor
Criteria

Inclusion Criteria:

  • age>18 years
  • histologically/cytologically proved diagnosis of NET
  • Grading G1, G2, G3 according to the classification WHO 2017
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04282083


Contacts
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Contact: Francesco Panzuto +390633775605 fpanzuto@ospedalesantandrea.it
Contact: Maria Rinzivillo +390633775605 mrinzivillo@ospedalesantandrea.it

Locations
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Italy
Istituto Clinico Humanitas Recruiting
Rozzano, Milan, Italy, 20089
Contact: Valeria Smiroldo    0039 02 8224 7731    valeria.smiroldo@cancercenter.humanitas.it   
Contact: Erica Morgante    0039 02 8224 4095    erica.morgante@cancercenter.humanitas.it   
Azienda Ospedaliera Universitaria Consorziale Policlinico Recruiting
Bari, Italy, 70124
Contact: Mauro Cives    +390805592859    mauro.cives@uniba.it   
Contact: Anna Ragno    +390805592759    ragnoanna@tiscali.it   
Azienda Ospedaliera Universitaria Policlinico S. Orsola Malpighi Recruiting
Bologna, Italy, 40100
Contact: Davide Campana    +390512143067    davide.campana@unibo.it   
Contact: Giuseppe Lamberti    +390512143067    giuseppe.lamberti8@unibo.it   
Ospedale Maggiore Carlo Alberto Pizzardi Active, not recruiting
Bologna, Italy, 40133
San Raffaele Hospital Recruiting
Milan, Italy, 20132
Contact: MASSIMO FALCONI    3397473192    falconi.massimo@hsr.it   
IRCCS Istituto Nazionale Tumori Active, not recruiting
Milan, Italy, 20133
Istituti Fisioterapici Ospitalieri Active, not recruiting
Roma, Italy, 00144
Sant'Andrea Hospital Recruiting
Rome, Italy, 00189
Contact: Francesco Panzuto    +390633775605    fpanzuto@ospedalesantandrea.it   
Contact: Maria Rinzivillo    +390633775605    mrinzivillo@ospedalesantandrea.it   
Sponsors and Collaborators
Italian Association Neuroendocrine Tumors
Investigators
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Principal Investigator: MASSIMO FALCONI San Raffaele Hospital
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Responsible Party: Italian Association Neuroendocrine Tumors
ClinicalTrials.gov Identifier: NCT04282083    
Other Study ID Numbers: 001
First Posted: February 24, 2020    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Italian Association Neuroendocrine Tumors:
GEP-NETs
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue