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

Ipsen404 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

404

Conditions

Gastroenteropancreatic Neuroendocrine Tumors

Interventions

This is a non-interventional study. Patients will be treated with any intervention deemed appropriate by the patient's physician.OTHER

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (25)

Unnamed facility

Aarhus, Denmark

Unnamed facility

Copenhagen, Denmark

Outcomes

Primary Outcomes

Number of Participants With Progression Free Survival

Time frame: Up to 60 months

Secondary Outcomes

Change in oncological biomarker levels

Time frame: 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

Data from ClinicalTrials.gov

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