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

Gastroenteropancreatic Neuroendocrine Tumors Clinical Trial

— EXPLAIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02630654
• Other study ID #: A-99-52030-286
• Status: Completed
• Start date: March 24, 2014
• Est. completion date: November 9, 2021

Study information

• Verified date: December 2021
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 404
• Est. completion date: November 9, 2021
• Est. primary completion date: November 9, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastroenteropancreatic Neuroendocrine Tumors
• Neuroendocrine Tumors

Intervention

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

Locations

Country	Name	City	State
Estonia	North Estonia Medical Center	Tallinn
Latvia	Pauls Stradins Clinical University Hospital	Riga
Latvia	Riga East University Hospital	Riga
Lithuania	The Hospital of Lithuanian Health Science	Kaunas
Lithuania	Klaipeda University Hospital	Klaipeda
Lithuania	National Cancer Institute	Vilnius
Lithuania	Vilnius University Hospital	Vilnius
Sweden	Karolinska Universitetssjukhuset Bröst - och Endokrinkirurgiska kliniken	Stockholm
Sweden	Södersjukhuset	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Progression Free Survival		Up to 60 months
Secondary	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