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

NCT ID: NCT02630654

Last Updated: 2021-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

404 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-24

Study Completion Date

2021-11-09

Brief Summary

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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).

Detailed Description

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Conditions

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Gastroenteropancreatic Neuroendocrine Tumors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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GEP NETs

Patients with a suspected diagnosis of metastatic GEP NETs

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

Intervention Type OTHER

Healthy controls

Healthy controls matched by age and gender.

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

Intervention Type OTHER

Interventions

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ipsen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

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Aarhus, , Denmark

Site Status

Copenhagen, , Denmark

Site Status

Odense, , Denmark

Site Status

North Estonia Medical Center

Tallinn, , Estonia

Site Status

Helsinki, , Finland

Site Status

Oulu, , Finland

Site Status

Tampere, , Finland

Site Status

Pauls Stradins Clinical University Hospital

Riga, , Latvia

Site Status

Riga East University Hospital

Riga, , Latvia

Site Status

The Hospital of Lithuanian Health Science

Kaunas, , Lithuania

Site Status

Klaipėda University Hospital

Klaipėda, , Lithuania

Site Status

National Cancer Institute

Vilnius, , Lithuania

Site Status

Vilnius University Hospital

Vilnius, , Lithuania

Site Status

Bergen, , Norway

Site Status

Oslo, , Norway

Site Status

Stavanger, , Norway

Site Status

Trondheim, , Norway

Site Status

Gothenburg, , Sweden

Site Status

Jönköping, , Sweden

Site Status

Lund, , Sweden

Site Status

Örebro, , Sweden

Site Status

Karolinska Universitetssjukhuset Bröst - och Endokrinkirurgiska kliniken

Stockholm, , Sweden

Site Status

Södersjukhuset

Stockholm, , Sweden

Site Status

Umeå, , Sweden

Site Status

Uppsala, , Sweden

Site Status

Countries

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Denmark Estonia Finland Latvia Lithuania Norway Sweden

References

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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.

Reference Type DERIVED
PMID: 32721955 (View on PubMed)

Other Identifiers

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A-99-52030-286

Identifier Type: -

Identifier Source: org_study_id