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

Exploratory, Non-Interventional Study For Evaluating The Diagnostic, Prognostic And Response-Predictive 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).

Study Overview

• Status: Completed
• Conditions: Gastroenteropancreatic Neuroendocrine Tumors
• Intervention / Treatment: Other: This is a non-interventional study. Patients will be treated with any intervention deemed appropriate by the patient's physician.

• Study Type: Observational
• Enrollment (Actual): 404

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark
  • København, Denmark
  • Odense, Denmark
• Estonia
  • Tallinn, Estonia
    • North Estonia Medical Center
• Finland
  • Helsinki, Finland
  • Oulu, Finland
  • Tampere, Finland
• Latvia
  • Riga, Latvia
    • Pauls Stradins Clinical University Hospital
  • Riga, Latvia
    • Riga East University Hospital
• Lithuania
  • Kaunas, Lithuania
    • The Hospital of Lithuanian Health Science
  • Klaipėda, Lithuania
    • Klaipeda University Hospital
  • Vilnius, Lithuania
    • National Cancer Institute
  • Vilnius, Lithuania
    • Vilnius University Hospital
• Norway
  • Bergen, Norway
  • Oslo, Norway
  • Stavanger, Norway
  • Trondheim, Norway
• Sweden
  • Gothenburg, Sweden
  • Jönköping, Sweden
  • Lund, Sweden
  • Stockholm, Sweden
    • Södersjukhuset
  • Stockholm, Sweden
    • Karolinska Universitetssjukhuset Bröst - och Endokrinkirurgiska kliniken
  • Umea, Sweden
  • Uppsala, Sweden
  • Örebro, Sweden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients from a specialist clinic with a suspected diagnosis of metastatic GEP NETs and healthy controls matched by age and gender.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
GEP NETs; Patients with a suspected diagnosis of metastatic GEP NETs	Other: This is a non-interventional study. Patients will be treated with any intervention deemed appropriate by the patient's physician.
Healthy controls; Healthy controls matched by age and gender.	Other: This is a non-interventional study. Patients will be treated with any intervention deemed appropriate by the patient's physician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Progression Free Survival	Up to 60 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Ipsen

Publications and helpful links

General Publications

• Kjellman M, Knigge U, Welin S, Thiis-Evensen E, Gronbaek H, Schalin-Jantti C, Sorbye H, Joergensen MT, Johanson V, Metso S, Waldum H, Soreide JA, Ebeling T, Lindberg F, Landerholm K, Wallin G, Salem F, Schneider MDP, Belusa R. A Plasma Protein Biomarker Strategy for Detection of Small Intestinal Neuroendocrine Tumors. Neuroendocrinology. 2021;111(9):840-849. doi: 10.1159/000510483. Epub 2020 Jul 28.

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2014
• Primary Completion (Actual): November 9, 2021
• Study Completion (Actual): November 9, 2021

Study Registration Dates

• First Submitted: December 11, 2015
• First Submitted That Met QC Criteria: December 11, 2015
• First Posted (Estimate): December 15, 2015

Study Record Updates

• Last Update Posted (Actual): December 7, 2021
• Last Update Submitted That Met QC Criteria: December 6, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors
• Other Study ID Numbers: A-99-52030-286