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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 : Recruiting
First Posted : December 15, 2015
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Ipsen

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 Type : Observational
Estimated Enrollment : 400 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 : December 2021
Estimated Study Completion Date : December 2021


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.



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


Information from the National Library of Medicine

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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.

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


Contacts
Contact: Ipsen Recruitment Enquiries clinical.trials@ipsen.com

Locations
Denmark
Recruiting
Aarhus, Denmark
Recruiting
København, Denmark
Recruiting
Odense, Denmark
Estonia
North Estonia Medical Center Recruiting
Tallinn, Estonia
Finland
Active, not recruiting
Helsinki, Finland
Recruiting
Oulu, Finland
Recruiting
Tampere, Finland
Latvia
Pauls Stradins Clinical University Hospital Recruiting
Riga, Latvia
Riga East University Hospital Active, not recruiting
Riga, Latvia
Lithuania
The Hospital of Lithuanian Health Science Recruiting
Kaunas, Lithuania
Klaipėda University Hospital Active, not recruiting
Klaipėda, Lithuania
National Cancer Institute Recruiting
Vilnius, Lithuania
Vilnius University Hospital Active, not recruiting
Vilnius, Lithuania
Norway
Recruiting
Bergen, Norway
Recruiting
Oslo, Norway
Active, not recruiting
Stavanger, Norway
Active, not recruiting
Trondheim, Norway
Sweden
Recruiting
Gothenburg, Sweden
Recruiting
Jönköping, Sweden
Active, not recruiting
Lund, Sweden
Karolinska Universitetssjukhuset Bröst - och Endokrinkirurgiska kliniken Recruiting
Stockholm, Sweden
Södersjukhuset Withdrawn
Stockholm, Sweden
Recruiting
Umea, Sweden
Recruiting
Uppsala, Sweden
Recruiting
Örebro, Sweden
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Ipsen Medical Director Ipsen

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT02630654     History of Changes
Other Study ID Numbers: A-99-52030-286
First Posted: December 15, 2015    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
Neuroendocrine Tumors
Intestinal Neoplasms
Pancreatic Neoplasms
Stomach Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Stomach Diseases