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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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 Summary:
Sponsor: Ipsen

Current Primary Outcome: Number of Participants With Progression Free Survival [ Time Frame: Up to 60 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: 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 ]

Original Secondary Outcome: Same as current

Information By: Ipsen

Dates:
Date Received: December 11, 2015
Date Started: March 2014
Date Completion: December 2019
Last Updated: May 4, 2017
Last Verified: May 2017