SwissNET - a Registry for Neuroendocrine Tumours in Switzerland

Neuroendocrine Tumors Clinical Trial

— SwissNET  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01039922
• Other study ID #: BAG 035.0002-20/19
• Secondary ID: 395/2014
• Status: Recruiting
• Start date: January 2008
• Est. completion date: January 2028

Study information

• Verified date: January 2020
• Source: University Hospital Inselspital, Berne
• Contact: Alexander Siebenhuener, MD
• Phone: ++41 44 255 2214
• Email: Alexander.Siebenhuener[@]usz.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1245
• Est. completion date: January 2028
• Est. primary completion date: January 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Neuroendocrine tumor irrespective of primary tumor location

• Diagnosis in Switzerland

• Given informed consent

Related Conditions & MeSH terms

• Carcinoid Tumor
• Neoplasms
• Neuroendocrine Tumors

Locations

Country	Name	City	State
Switzerland	Kantonsspital Aarau	Aarau
Switzerland	Spitalnetz Bern Aarberg	Aarberg
Switzerland	Bezirksspital Affoltern	Affoltern am Albis
Switzerland	Kantonsspital Uri, Altdorf	Altdorf
Switzerland	St. Claraspital	Basel
Switzerland	Universitätsspital Basel	Basel
Switzerland	Istituto oncologico della Svizzera italiana	Bellinzona
Switzerland	Div. of Endocrinology, Diabetes and Clinical Nutrition, Bern University Hospital	Bern
Switzerland	Spital Tiefenau, Spitalnetz Bern	Bern
Switzerland	Zieglerspital Bern	Bern
Switzerland	Spitalzentrum Biel - Bienne	Biel
Switzerland	Kantonsspital Bruderholz	Bruderholz
Switzerland	Regionsspital Emmental	Burgdorf
Switzerland	Kantonsspital Chur	Chur
Switzerland	Private practise Dr. Mannhart	Churwalden
Switzerland	Hôpital du Jura	Delémont
Switzerland	Spital Dornach	Dornach
Switzerland	Regionalspital Einsiedeln	Einsiedeln
Switzerland	Hôpitaux Universitaires de Genève	Geneva
Switzerland	Spital Grabs	Grabs
Switzerland	See-Spital Horgen	Horgen
Switzerland	Spital Zimmerberg	Horgen
Switzerland	Fmi Spital Interlaken	Interlaken
Switzerland	Spital Lachen	Lachen
Switzerland	Spital Region Oberaargau	Langenthal
Switzerland	Kantonsspital Laufen	Laufen
Switzerland	Centre hospitalier universitaire vaudois, CHUV	Lausanne
Switzerland	Kantonsspital Liestal	Liestal
Switzerland	Hirslandenklinik St. Anna	Luzern
Switzerland	Kantonsspital Luzern	Luzern
Switzerland	Kantonsspital Sursee, Luzern	Luzern
Switzerland	Kreisspital Männedorf	Männedorf
Switzerland	Kantonsspital Münsterlingen	Münsterlingen
Switzerland	Kantonsspital Olten	Olten
Switzerland	Gesundheitszentrum Fricktal	Rheinfelden
Switzerland	Kantonsspital Obwalden	Sarnen
Switzerland	Spital Limmattal	Schlieren
Switzerland	Spital Schwyz	Schwyz
Switzerland	Privatpraxis Dr. H.J. Poths	Seuzach
Switzerland	Centre hospitalier du centre du Valais	Sion
Switzerland	Bürgerspital Solothurn	Solothurn
Switzerland	Kantonsspital St. Gallen	St. Gallen
Switzerland	Kantonsspital Nidwalden	Stans
Switzerland	Thun Spital STS AG	Thun
Switzerland	Spital Uster	Uster
Switzerland	Regionalspital Visp	Visp
Switzerland	Kantonsspital Winterthur	Winterthur
Switzerland	Kantonsspital Wolhusen	Wolhusen
Switzerland	Spital Zollikerberg	Zollikerberg
Switzerland	Zuger Kantonsspital AG	Zug
Switzerland	Pathologie Medica Zürich	Zürich
Switzerland	Stadtspital Triemli	Zürich
Switzerland	Stadtspital Waid	Zürich
Switzerland	Universitätsspital Zürich	Zürich
Switzerland	STS AG Spital Zweisimmen	Zweisimmen

Sponsors (15)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	Cantonal Hospital of St. Gallen, Ente Ospedaliero Cantonale, Bellinzona, Kantonsspital Graubuenden, Kantonsspital Liestal, Luzerner Kantonsspital, Spital Limmattal Schlieren, Spital STS AG, Spitalnetz Bern, Triemlispital Zurich, University Hospital, Basel, Switzerland, University Hospital, Geneva, University Hospital, Zürich, University of Lausanne Hospitals, Waid City Hospital, Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor-related mortality		Every 5 years
Secondary	Incidence of GEP-NET in Switzerland		Every 5 years
Secondary	Effect of specific treatment strategies		Every 5 years