SwissNET - a Registry for Neuroendocrine Tumours in Switzerland

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


Condition
Neuroendocrine Tumors
Carcinoid Tumor

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: SwissNET - a Prospective Registry of Patients With Neuroendocrine Tumours in Switzerland

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Tumor-related mortality [ Time Frame: Every 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 500
Study Start Date: January 2008
Estimated Study Completion Date: January 2028
Estimated Primary Completion Date: January 2028 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients with a histologically confirmed diagnosis of a neuroendocrine tumour, either of gastrointestinal or pulmonary origin.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • Gastroenteropathic neuroendocrine tumor
  • Pulmonary neuroendocrine tumor (typical or atypical carcinoid)
  • Diagnosis in Switzerland
  • Given informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01039922

Contacts
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

Locations
Switzerland
Div. of Endocrinology, Diabetes and Clinical Nutrition, Bern University Hospital Recruiting
Bern, Switzerland, 3010
Principal Investigator: Christoph Stettler, MD         
Sponsors and Collaborators
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
Investigators
Study Director: Aurel Perren, MD Institute of Pathology, University of Bern, Bern
  More Information

Additional Information:
No publications provided

Responsible Party: SwissNET, University Hospital Bern, c/o PD Dr. Christoph Stettler
ClinicalTrials.gov Identifier: NCT01039922     History of Changes
Other Study ID Numbers: BAG 035.0002-20/19
Study First Received: December 24, 2009
Last Updated: January 16, 2012
Health Authority: Switzerland: Federal Office of Public Health (Bundesamt fuer Gesundheit)

Keywords provided by University Hospital Inselspital, Berne:
Neuroendocrine Tumors
Registries

Additional relevant MeSH terms:
Carcinoid Tumor
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on July 24, 2014