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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02630654

Acronym

EXPLAIN

Enrollment

404

Registered

2015-12-15

Start date

2014-03-24

Completion date

2021-11-09

Last updated

2021-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroenteropancreatic Neuroendocrine Tumors

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).

Interventions

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

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

Countries

Denmark, Estonia, Finland, Latvia, Lithuania, Norway, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026