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

Sponsor

Ipsen (Industry)

Overall Status

Completed

CT.gov ID

NCT02630654

Collaborator

(none)

404

Enrollment

Locations

91.6

Actual Duration (Months)

16.2

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Gastroenteropancreatic Neuroendocrine Tumors	Other: This is a non-interventional study. Patients will be treated with any intervention deemed appropriate by the patient's physician.

Study Design

Study Type:

Observational

Actual Enrollment :

404 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 24, 2014

Actual Primary Completion Date :

Nov 9, 2021

Actual Study Completion Date :

Nov 9, 2021

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Number of Participants With Progression Free Survival [Up to 60 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	Country
1		Aarhus	Denmark
2		København	Denmark
3		Odense	Denmark
4	North Estonia Medical Center	Tallinn	Estonia
5		Helsinki	Finland
6		Oulu	Finland
7		Tampere	Finland
8	Pauls Stradins Clinical University Hospital	Riga	Latvia
9	Riga East University Hospital	Riga	Latvia
10	The Hospital of Lithuanian Health Science	Kaunas	Lithuania
11	Klaipėda University Hospital	Klaipėda	Lithuania
12	National Cancer Institute	Vilnius	Lithuania
13	Vilnius University Hospital	Vilnius	Lithuania
14		Bergen	Norway
15		Oslo	Norway
16		Stavanger	Norway
17		Trondheim	Norway
18		Gothenburg	Sweden
19		Jönköping	Sweden
20		Lund	Sweden
21	Karolinska Universitetssjukhuset Bröst - och Endokrinkirurgiska kliniken	Stockholm	Sweden
22	Södersjukhuset	Stockholm	Sweden
23		Umea	Sweden
24		Uppsala	Sweden
25		Örebro	Sweden

Sponsors and Collaborators

Ipsen

Investigators

Study Director: Ipsen Medical Director, Ipsen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ipsen

ClinicalTrials.gov Identifier:

NCT02630654

Other Study ID Numbers:

A-99-52030-286

First Posted:

Dec 15, 2015

Last Update Posted:

Dec 7, 2021

Last Verified:

Dec 1, 2021

Additional relevant MeSH terms:

Neuroendocrine Tumors

Study Results

No Results Posted as of Dec 7, 2021