Study For Evaluating The Value Of A Multi Biomarker Approach In Metastatic GEP NETs

Study Overview
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Brief Summary
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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).

Official Title
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Exploratory, Non-Interventional Study For Evaluating The Diagnostic, Prognostic And Response-Predictive Value Of A Multi Biomarker Approach In Metastatic GEP NETs

Conditions
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Gastroenteropancreatic Neuroendocrine Tumors

Intervention / Treatment
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* Other: This is a non-interventional study. Patients will be treated with any intervention deemed appropriate by the patient's physician.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GEP NETs<br>Patients with a suspected diagnosis of metastatic GEP NETs | Other: This is a non-interventional study. Patients will be treated with any intervention deemed appropriate by the patient's physician.<br> <br> |
| Healthy controls<br>Healthy controls matched by age and gender. | Other: This is a non-interventional study. Patients will be treated with any intervention deemed appropriate by the patient's physician.<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Progression Free Survival |  | Up to 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |