Clinical trial NCT02630654: Study For Evaluating The Value Of A Multi Biomarker Approach In Metastatic GEP NETs
Official title: Exploratory, Non-Interventional Study For Evaluating The Diagnostic, Prognostic And Response-Predictive Value Of A Multi Biomarker Approach In Metastatic GEP NETs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroenteropancreatic Neuroendocrine Tumors
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2015-12-15
Enrollment: 404
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Progression Free Survival
timeFrame: Up to 60 months
Secondary outcomes:
measure: Change in oncological biomarker levels
timeFrame: 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
Other outcomes:
Locations:
city: Aarhus
country: Denmark
city: København
country: Denmark
city: Odense
country: Denmark
city: Tallinn
country: Estonia
facility: North Estonia Medical Center
city: Helsinki
country: Finland
city: Oulu
country: Finland
city: Tampere
country: Finland
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Riga
country: Latvia
facility: Riga East University Hospital
city: Kaunas
country: Lithuania
facility: The Hospital of Lithuanian Health Science
city: Klaipėda
country: Lithuania
facility: Klaipėda University Hospital
city: Vilnius
country: Lithuania
facility: National Cancer Institute
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital
city: Bergen
country: Norway
city: Oslo
country: Norway
city: Stavanger
country: Norway
city: Trondheim
country: Norway
city: Gothenburg
country: Sweden
city: Jönköping
country: Sweden
city: Lund
country: Sweden
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Bröst - och Endokrinkirurgiska kliniken
city: Stockholm
country: Sweden
facility: Södersjukhuset
city: Umea
country: Sweden
city: Uppsala
country: Sweden
city: Örebro
country: Sweden
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.