Study For Evaluating The Value Of A Multi Biomarker Approach In Metastatic GEP NETs
- Conditions
- Gastroenteropancreatic Neuroendocrine Tumors
- Registration Number
- NCT02630654
- Lead Sponsor
- Ipsen
- Brief Summary
This exploratory study aims to evaluate the diagnostic, prognostic and response predictive value of a multi biomarker strategy in patients with Gastroenteropancreatic Neuroendocrine Tumors (GEP NETs) originating from the midgut or pancreas. Using a recently developed methodology enabling the evaluation of 92 concomitant cancer biomarkers will provide an interesting approach to solve this question (Lundberg et al 2011).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 404
- Provision of written informed consent prior to any study related procedures.
- Suspected of suffering from a metastatic midgut NET or Pancreatic non-functional NET (WHO grade 1 or 2, up to 10% Ki67).
- Male or female aged 18 or older.
- Previously treated for the NET disease with pharmaceutical treatment, Peptide Receptor Radionuclide Therapy (PRRT) or radiation therapy(surgery of primary tumour is accepted)
- Has any mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.
- Suffering from a malignant disease or previously treated for a malignant disease within the last 6 months.
- Suffering from a chronic inflammatory disease.
- Suffering from a renal and/or liver disease.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants With Progression Free Survival Up to 60 months
- Secondary Outcome Measures
Name Time Method Change in oncological biomarker levels Baseline visit and follow-up visit [i.e. every 3 months during the first year, every 6 months for the remainder of the study] up to 60 months
Trial Locations
- Locations (9)
North Estonia Medical Center
🇪🇪Tallinn, Estonia
Pauls Stradins Clinical University Hospital
🇱🇻Riga, Latvia
Riga East University Hospital
🇱🇻Riga, Latvia
The Hospital of Lithuanian Health Science
🇱🇹Kaunas, Lithuania
Klaipėda University Hospital
🇱🇹Klaipėda, Lithuania
National Cancer Institute
🇱🇹Vilnius, Lithuania
Vilnius University Hospital
🇱🇹Vilnius, Lithuania
Karolinska Universitetssjukhuset Bröst - och Endokrinkirurgiska kliniken
🇸🇪Stockholm, Sweden
Södersjukhuset
🇸🇪Stockholm, Sweden
North Estonia Medical Center🇪🇪Tallinn, Estonia