Study For Evaluating The Value Of A Multi Biomarker Approach In Metastatic GEP NETs (EXPLAIN)
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| ClinicalTrials.gov Identifier: NCT02630654 |
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Recruitment Status :
Recruiting
First Posted : December 15, 2015
Last Update Posted : September 28, 2018
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Sponsor:
Ipsen
Information provided by (Responsible Party):
Ipsen
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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 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 |
Resource links provided by the National Library of Medicine
| Group/Cohort | Intervention/treatment |
|---|---|
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GEP NETs
Patients with a suspected diagnosis of metastatic GEP NETs
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Other: This is a non-interventional study. Patients will be treated with any intervention deemed appropriate by the patient's physician. |
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Healthy controls
Healthy controls matched by age and gender.
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Other: This is a non-interventional study. Patients will be treated with any intervention deemed appropriate by the patient's physician. |
Primary Outcome Measures :
- Number of Participants With Progression Free Survival [ Time Frame: Up to 60 months ]
Secondary Outcome Measures :
- 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:
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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 |