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

Completed

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

• Registration Number: NCT02630654
• Lead Sponsor: Ipsen

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 Description

Not available

Study Timeline

• Study Start: 2014-03-24
• Study First Submitted: 2015-12-11
• Study First Submitted QC: 2015-12-11
• Study First Posted: 2015-12-15
• Primary Completion: 2021-11-09
• Study Completion: 2021-11-09
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-06
• Last Update Posted: 2021-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 404

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of Participants With Progression Free Survival	Up to 60 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (9)

Riga East University Hospital; 🇱🇻 Riga, Latvia

North Estonia Medical Center; 🇪🇪 Tallinn, Estonia

Pauls Stradins Clinical University Hospital; 🇱🇻 Riga, Latvia

The Hospital of Lithuanian Health Science; 🇱🇹 Kaunas, Lithuania

National Cancer Institute; 🇱🇹 Vilnius, Lithuania

Klaipėda University Hospital; 🇱🇹 Klaipėda, Lithuania

Vilnius University Hospital; 🇱🇹 Vilnius, Lithuania

Karolinska Universitetssjukhuset Bröst - och Endokrinkirurgiska kliniken; 🇸🇪 Stockholm, Sweden

Södersjukhuset; 🇸🇪 Stockholm, Sweden