Clinical trial NCT01039922: SwissNET - a Registry for Neuroendocrine Tumours in Switzerland
Official title: SwissNET - a Prospective Registry of Patients With Neuroendocrine Tumours in Switzerland
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neuroendocrine Tumors
Carcinoid Tumor
Keywords: Neuroendocrine Tumors
Registries
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Cantonal Hospital of St. Gallen
name: University Hospital, Basel, Switzerland
name: University Hospital, Geneva
name: University of Lausanne Hospitals
name: University Hospital, Zürich
name: Triemlispital Zurich
name: Spitalnetz Bern
name: Ente Ospedaliero Cantonale, Bellinzona
name: Luzerner Kantonsspital
name: Kantonsspital Liestal
name: Kantonsspital Graubuenden
name: Spital Limmattal Schlieren
name: Waid City Hospital, Zurich
name: Spital STS AG
First posted: 2009-12-25
Enrollment: 1245
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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 criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Tumor-related mortality
timeFrame: Every 5 years
Secondary outcomes:
measure: Incidence of GEP-NET in Switzerland
timeFrame: Every 5 years
measure: Effect of specific treatment strategies
timeFrame: Every 5 years
Other outcomes:
Locations:
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
city: Aarberg
country: Switzerland
facility: Spitalnetz Bern Aarberg
city: Affoltern am Albis
country: Switzerland
facility: Bezirksspital Affoltern
city: Altdorf
country: Switzerland
facility: Kantonsspital Uri, Altdorf
city: Basel
country: Switzerland
facility: St. Claraspital
city: Basel
country: Switzerland
facility: Universitätsspital Basel
city: Bellinzona
country: Switzerland
facility: Istituto oncologico della Svizzera italiana
city: Bern
country: Switzerland
facility: Div. of Endocrinology, Diabetes and Clinical Nutrition, Bern University Hospital
city: Bern
country: Switzerland
facility: Spital Tiefenau, Spitalnetz Bern
city: Bern
country: Switzerland
facility: Zieglerspital Bern
city: Biel
country: Switzerland
facility: Spitalzentrum Biel - Bienne
city: Bruderholz
country: Switzerland
facility: Kantonsspital Bruderholz
city: Burgdorf
country: Switzerland
facility: Regionsspital Emmental
city: Churwalden
country: Switzerland
facility: Private practise Dr. Mannhart
city: Chur
country: Switzerland
facility: Kantonsspital Chur
city: Delémont
country: Switzerland
facility: Hôpital du Jura
city: Dornach
country: Switzerland
facility: Spital Dornach
city: Einsiedeln
country: Switzerland
facility: Regionalspital Einsiedeln
city: Geneva
country: Switzerland
facility: Hôpitaux Universitaires de Genève
city: Grabs
country: Switzerland
facility: Spital Grabs
city: Horgen
country: Switzerland
facility: See-Spital Horgen
city: Horgen
country: Switzerland
facility: Spital Zimmerberg
city: Interlaken
country: Switzerland
facility: Fmi Spital Interlaken
city: Lachen
country: Switzerland
facility: Spital Lachen
city: Langenthal
country: Switzerland
facility: Spital Region Oberaargau
city: Laufen
country: Switzerland
facility: Kantonsspital Laufen
city: Lausanne
country: Switzerland
facility: Centre hospitalier universitaire vaudois, CHUV
city: Liestal
country: Switzerland
facility: Kantonsspital Liestal
city: Luzern
country: Switzerland
facility: Hirslandenklinik St. Anna
city: Luzern
country: Switzerland
facility: Kantonsspital Luzern
city: Luzern
country: Switzerland
facility: Kantonsspital Sursee, Luzern
city: Männedorf
country: Switzerland
facility: Kreisspital Männedorf
city: Münsterlingen
country: Switzerland
facility: Kantonsspital Münsterlingen
city: Olten
country: Switzerland
facility: Kantonsspital Olten
city: Rheinfelden
country: Switzerland
facility: Gesundheitszentrum Fricktal
city: Sarnen
country: Switzerland
facility: Kantonsspital Obwalden
city: Schlieren
country: Switzerland
facility: Spital Limmattal
city: Schwyz
country: Switzerland
facility: Spital Schwyz
city: Seuzach
country: Switzerland
facility: Privatpraxis Dr. H.J. Poths
city: Sion
country: Switzerland
facility: Centre hospitalier du centre du Valais
city: Solothurn
country: Switzerland
facility: Bürgerspital Solothurn
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
city: Stans
country: Switzerland
facility: Kantonsspital Nidwalden
city: Thun
country: Switzerland
facility: Thun Spital STS AG
city: Uster
country: Switzerland
facility: Spital Uster
city: Visp
country: Switzerland
facility: Regionalspital Visp
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
city: Wolhusen
country: Switzerland
facility: Kantonsspital Wolhusen
city: Zollikerberg
country: Switzerland
facility: Spital Zollikerberg
city: Zug
country: Switzerland
facility: Zuger Kantonsspital AG
city: Zweisimmen
country: Switzerland
facility: STS AG Spital Zweisimmen
city: Zürich
country: Switzerland
facility: Pathologie Medica Zürich
city: Zürich
country: Switzerland
facility: Stadtspital Triemli
city: Zürich
country: Switzerland
facility: Stadtspital Waid
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich
Study officials:
affiliation: Institute of Pathology, University of Bern, Bern
name: Aurel Perren, MD
role: STUDY_DIRECTOR
References: