SwissNET - a Registry for Neuroendocrine Tumours in Switzerland

Recruiting

• Conditions: Neuroendocrine Tumors; Carcinoid Tumor

• Registration Number: NCT01039922
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2009-12-24
• Study First Submitted QC: 2009-12-24
• Study First Posted: 2009-12-25
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-20
• Last Update Posted: 2020-01-23
• Primary Completion: 2028-01
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1245

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tumor-related mortality	Every 5 years

Secondary Outcome Measures

Name	Time	Method
Effect of specific treatment strategies	Every 5 years
Incidence of GEP-NET in Switzerland	Every 5 years

Trial Locations

Locations (55)

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

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