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

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).

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 9, 2021

Interventions

  • Other: This is a non-interventional study. Patients will be treated with any intervention deemed appropriate by the patient’s physician.

Arms, Groups and Cohorts

  • GEP NETs
    • Patients with a suspected diagnosis of metastatic GEP NETs
  • Healthy controls
    • Healthy controls matched by age and gender.

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants With Progression Free Survival
    • Time Frame: Up to 60 months

Secondary Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Ipsen
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ipsen Medical Director, Study Director, Ipsen

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