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

Ipsen9 sites in 4 countries404 target enrollmentMarch 24, 2014

ConditionsGastroenteropancreatic Neuroendocrine Tumors

Overview

Phase: N/A
Intervention: Not specified
Conditions: Gastroenteropancreatic Neuroendocrine Tumors
Sponsor: Ipsen
Enrollment: 404
Locations: 9
Primary Endpoint: Number of Participants With Progression Free Survival
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

March 24, 2014

End Date

November 9, 2021

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Ipsen

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Number of Participants With Progression Free Survival

Time Frame: Up to 60 months

Secondary Outcomes

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)