Skip to main content
OpenTrials
Completed

NCT Number: NCT02630654

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gastroenteropancreatic Neuroendocrine Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other

Primary outcomes

  1. Number of Participants With Progression Free Survival

    Time frame: Up to 60 months

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

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

Acronym: EXPLAIN

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Dec 15, 2015
Registry last updated
Dec 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.