Protocol ITANET - Registry

January 24, 2024 updated by: Italian Association Neuroendocrine Tumors

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.

Study Overview

Status

Recruiting

Conditions

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:

    1. The data are acceptable: in this case the data will be validated;
    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.

Study Type

Observational

Enrollment (Estimated)

3600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients affected by gastro-entero pancreatic neuroendocrine or unknown primary tumor

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Italian Association Neuroendocrine Tumors

Investigators

  • Principal Investigator: MASSIMO FALCONI, San Raffaele Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2019

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2032

Study Registration Dates

First Submitted

February 3, 2020

First Submitted That Met QC Criteria

February 20, 2020

First Posted (Actual)

February 24, 2020

Study Record Updates

Last Update Posted (Actual)

January 25, 2024

Last Update Submitted That Met QC Criteria

January 24, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001 (NavyGHB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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