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Recruiting NCT01039922

SwissNET - a Registry for Neuroendocrine Tumours in Switzerland

Observational Neuroendocrine Tumors Carcinoid Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Neuroendocrine Tumors, Carcinoid Tumor. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

SwissNET - a Prospective Registry of Patients With Neuroendocrine Tumours in Switzerland

Overview

Gastroentero-pancreatic neuroendocrine tumours (GEP-NETs) are regarded as a fairly rare disease. They are derived from the neuroendocrine system of the gastrointestinal tract and the pancreas and share common clinical features. So far, there is still uncertainty about the cell biology and mechanistic regulation of these tumours. Therefore targeted treatment is limited and management challenging. Treatment options include surgery, medical and ablative therapy, and more recently peptide-receptor radionuclide therapy. In order to better understand the characteristics of GEP-NETs and to evaluate treatment strategies, the SwissNET registry aims at the collection of data from patients presenting with a GEP-NET in Switzerland. Data will be entered prospectively and anonymized in a specifically designed database after the patient has given informed consent. All hospitals and general practitioners are invited to report on patients with a GEP-NET diagnosis and to participate to the registry. Data will be evaluated within regular time frames, focussing on types of GEP-NETs, treatment modalities and patient outcomes (e.g. mortality, hospitalisation rate), thereby contributing to the better understanding of these tumours.

Detailed description

Background

Gastroentero-pancreatic neuroendocrine tumours (GEP-NETs) are generally classified as rare diseases. Little is known about their cell biology and their mechanistic regulation. During the last years, the incidence of GEP-NETs is continuously increasing worldwide. In parallel, novel treatment options are currently evaluated which may substantially improve prognosis of patients with NETs. Data on such tumours in Switzerland, however, is scarce and treatment strategies vary throughout the country.

Objective

To systematically and prospectively collect clinical information of patients with GEP-NETs in Switzerland based on a histologically confirmed diagnosis.

Methods

All NETs of both, gastrointestinal and pulmonary origin are included provided that patients have given informed consent. Data will be entered prospectively and anonymised in a specifically designed database. Contributing centres and general practitioners are visited by a study nurse, patient files are analysed and data is transferred to the database. In case of conflicting evidence, questions are resolved in collaboration with a review board of SwissNET. Evaluation of treatment modalities and patient outcomes (e.g. mortality, hospitalisation rate) will take place within regular time frames.

Primary outcome measures

  • Tumor-related mortality [Time frame: Every 5 years]
Secondary outcome measures (2)
  • Incidence of GEP-NET in Switzerland [Time frame: Every 5 years]
  • Effect of specific treatment strategies [Time frame: Every 5 years]

Eligibility criteria

Inclusion criteria

  • Neuroendocrine tumor irrespective of primary tumor location
  • Diagnosis in Switzerland
  • Given informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Switzerland · 55 centers
  • Kantonsspital Aarau — Aarau
  • Spitalnetz Bern Aarberg — Aarberg
  • Bezirksspital Affoltern — Affoltern am Albis
  • Kantonsspital Uri, Altdorf — Altdorf
  • St. Claraspital — Basel
  • Universitätsspital Basel — Basel
  • Istituto oncologico della Svizzera italiana — Bellinzona
  • Div. of Endocrinology, Diabetes and Clinical Nutrition, Bern University Hospital — Bern
  • … and 47 more centers

Identifiers

NCT: NCT01039922 · BAG 035.0002-20/19 · 395/2014

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗