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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GEP NETs | Patients with a suspected diagnosis of metastatic GEP NETs |
| |
| Healthy controls | Healthy controls matched by age and gender. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| This is a non-interventional study. Patients will be treated with any intervention deemed appropriate by the patient's physician. | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Progression Free Survival | Up to 60 months |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients from a specialist clinic with a suspected diagnosis of metastatic GEP NETs and healthy controls matched by age and gender.
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus | Denmark | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32721955 | Derived | 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. |
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Frozen plasma will be saved in a biobank
| Copenhagen |
| Denmark |
| Odense | Denmark |
| North Estonia Medical Center | Tallinn | Estonia |
| Helsinki | Finland |
| Oulu | Finland |
| Tampere | Finland |
| Pauls Stradins Clinical University Hospital | Riga | Latvia |
| Riga East University Hospital | Riga | Latvia |
| The Hospital of Lithuanian Health Science | Kaunas | Lithuania |
| Klaipėda University Hospital | Klaipėda | Lithuania |
| National Cancer Institute | Vilnius | Lithuania |
| Vilnius University Hospital | Vilnius | Lithuania |
| Bergen | Norway |
| Oslo | Norway |
| Stavanger | Norway |
| Trondheim | Norway |
| Gothenburg | Sweden |
| Jönköping | Sweden |
| Lund | Sweden |
| Örebro | Sweden |
| Karolinska Universitetssjukhuset Bröst - och Endokrinkirurgiska kliniken | Stockholm | Sweden |
| Södersjukhuset | Stockholm | Sweden |
| Umeå | Sweden |
| Uppsala | Sweden |