SwissNET - a Registry for Neuroendocrine Tumours in Switzerland

This study is currently recruiting participants.
Verified January 2012 by University Hospital Inselspital, Berne
Sponsor:
Collaborators:
Cantonal Hospital of St. Gallen
University Hospital, Basel, Switzerland
University Hospital, Geneva
University of Lausanne Hospitals
University of Zurich
Triemlispital Zurich
Spitalnetz Bern
Ente Ospedaliero Cantonale, Bellinzona
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01039922
First received: December 24, 2009
Last updated: January 16, 2012
Last verified: January 2012

December 24, 2009
January 16, 2012
January 2008
January 2028   (final data collection date for primary outcome measure)
Tumor-related mortality [ Time Frame: Every 5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01039922 on ClinicalTrials.gov Archive Site
  • Incidence of GEP-NET in Switzerland [ Time Frame: Every 5 years ] [ Designated as safety issue: No ]
  • Effect of specific treatment strategies [ Time Frame: Every 5 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
SwissNET - a Registry for Neuroendocrine Tumours in Switzerland
SwissNET - a Prospective Registry of Patients With Neuroendocrine Tumours in Switzerland

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients will be selected either through the report of a pathological institute or of any medical doctor within Switzerland treating patients with neuroendocrine tumours.

  • Neuroendocrine Tumors
  • Carcinoid Tumor
Not Provided
1
Patients with a histologically confirmed diagnosis of a neuroendocrine tumour, either of gastrointestinal or pulmonary origin.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
January 2028
January 2028   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Gastroenteropathic neuroendocrine tumor
  • Pulmonary neuroendocrine tumor (typical or atypical carcinoid)
  • Diagnosis in Switzerland
  • Given informed consent
Both
Not Provided
No
Contact: Christoph Stettler, MD ++41 31 632 40 70 christoph.stettler@insel.ch
Contact: Emanuel Christ, MD, PhD ++41 31 632 40 70 emanuel.christ@insel.ch
Switzerland
 
NCT01039922
BAG 035.0002-20/19
No
SwissNET, University Hospital Bern, c/o PD Dr. Christoph Stettler
University Hospital Inselspital, Berne
  • Cantonal Hospital of St. Gallen
  • University Hospital, Basel, Switzerland
  • University Hospital, Geneva
  • University of Lausanne Hospitals
  • University of Zurich
  • Triemlispital Zurich
  • Spitalnetz Bern
  • Ente Ospedaliero Cantonale, Bellinzona
Study Director: Aurel Perren, MD Institute of Pathology, University of Bern, Bern
University Hospital Inselspital, Berne
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP