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

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ClinicalTrials.gov Identifier: NCT02630654
Recruitment Status : Active, not recruiting
First Posted : December 15, 2015
Last Update Posted : December 20, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

Study Description
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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
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
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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 : March 2014
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. Number of Participants With Progression Free Survival [ Time Frame: Up to 60 months ]

Secondary Outcome Measures :
  1. Change in oncological biomarker levels [ Time Frame: 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 ]

Biospecimen Retention:   Samples With DNA
Frozen plasma will be saved in a biobank

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02630654


Locations
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Denmark
Aarhus, Denmark
København, Denmark
Odense, Denmark
Estonia
North Estonia Medical Center
Tallinn, Estonia
Finland
Helsinki, Finland
Oulu, Finland
Tampere, Finland
Latvia
Pauls Stradins Clinical University Hospital
Riga, Latvia
Riga East University Hospital
Riga, Latvia
Lithuania
The Hospital of Lithuanian Health Science
Kaunas, Lithuania
Klaipėda University Hospital
Klaipėda, Lithuania
National Cancer Institute
Vilnius, Lithuania
Vilnius University Hospital
Vilnius, Lithuania
Norway
Bergen, Norway
Oslo, Norway
Stavanger, Norway
Trondheim, Norway
Sweden
Gothenburg, Sweden
Jönköping, Sweden
Lund, Sweden
Karolinska Universitetssjukhuset Bröst - och Endokrinkirurgiska kliniken
Stockholm, Sweden
Umea, Sweden
Uppsala, Sweden
Örebro, Sweden
Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen
More Information
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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT02630654    
Other Study ID Numbers: A-99-52030-286
First Posted: December 15, 2015    Key Record Dates
Last Update Posted: December 20, 2019
Last Verified: December 2019
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue