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 :
Completed
First Posted : December 15, 2015
Last Update Posted : December 7, 2021
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Condition or disease | Intervention/treatment |
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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 |
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 24, 2014 |
Actual Primary Completion Date : | November 9, 2021 |
Actual Study Completion Date : | November 9, 2021 |

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. |
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. |
- Number of Participants With Progression Free Survival [ Time Frame: Up to 60 months ]
- 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

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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 |
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.

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

Study Director: | Ipsen Medical Director | Ipsen |
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 7, 2021 |
Last Verified: | December 2021 |
Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue |