Gastroenteropancreatic Neuroendocrine TumorsEXPLAINNCT02630654
Study For Evaluating The Value Of A Multi Biomarker Approach In Metastatic GEP NETs
An observational study of Gastroenteropancreatic Neuroendocrine Tumors, run by Ipsen at 25 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastroenteropancreatic Neuroendocrine Tumors
- What is being tested?
- This is a non-interventional study. Patients will be treated with any intervention deemed appropriate by the patient's physician.
- How many people
- 404 participants
- Where
- 25 sitesin 7 countries
- Study dates
- 24 Mar 2014to 9 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients from a specialist clinic with a suspected diagnosis of metastatic GEP NETs and healthy controls matched by age and gender.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
25 sites in 7 countries.
25 sites in 7 countries
Sweden8 sites
Study site
Gothenburg
Study site
Jönköping
Study site
Lund
Study site
Örebro
Karolinska Universitetssjukhuset Bröst - och Endokrinkirurgiska kliniken
Stockholm
Södersjukhuset
Stockholm
Study site
Umeå
Study site
Uppsala
Lithuania4 sites
The Hospital of Lithuanian Health Science
Kaunas
Klaipėda University Hospital
Klaipėda
National Cancer Institute
Vilnius
Vilnius University Hospital
Vilnius
Norway4 sites
Study site
Bergen
Study site
Oslo
Study site
Stavanger
Study site
Trondheim
Latvia2 sites
Pauls Stradins Clinical University Hospital
Riga
Riga East University Hospital
Riga
About this study
Official title: Exploratory, Non-Interventional Study For Evaluating The Diagnostic, Prognostic And Response-Predictive Value Of A Multi Biomarker Approach In Metastatic GEP NETs
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).
- Being tested
- This is a non-interventional study. Patients will be treated with any intervention deemed appropriate by the patient's physician.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is a non-interventional study. Patients will be treated with any intervention deemed appropriate by the patient's physician.Other
| Study group | Role | What they receive |
|---|---|---|
| GEP NETs | Patients with a suspected diagnosis of metastatic GEP NETs Receives: 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. Receives: Other: This is a non-interventional study. Patients will be treated with any intervention deemed appropriate by the patient's physician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Progression Free Survival
Measured: Up to 60 months
Secondary outcomes (1)
Change in oncological biomarker levels
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2015 (estimated)
- Study start24 Mar 2014
- Primary completion9 Nov 2021
- Study completion9 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroenteropancreatic Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 404 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02630654
- Sponsor's protocol ID
- A-99-52030-286
- Acronym
- EXPLAIN
- Status last verified
- Dec 2021
- First submitted
- 11 Dec 2015
- Last updated
- 7 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32721955
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory, Non-Interventional Study For Evaluating The Diagnostic, Prognostic And Response-Predictive Value Of A Multi Biomarker Approach In Metastatic GEP NETs
- ClinicalTrials.gov ID
- NCT02630654
- Acronym / sponsor ID
- EXPLAIN / A-99-52030-286
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 24 Mar 2014 (actual)
- Primary completion
- 9 Nov 2021 (actual)
- Study completion
- 9 Nov 2021 (actual)
- First posted
- 15 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GEP NETs | – | Other: This is a non-interventional study. Patients will be treated with any intervention deemed appropriate by the patient's physician.Patients with a suspected diagnosis of metastatic GEP NETs |
| Healthy controls | – | Other: This is a non-interventional study. Patients will be treated with any intervention deemed appropriate by the patient's physician.Healthy controls matched by age and gender. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from a specialist clinic with a suspected diagnosis of metastatic GEP NETs and healthy controls matched by age and gender.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This is a non-interventional study. Patients will be treated with any intervention deemed appropriate by the patient's physician. | Other | GEP NETs, Healthy controls |
Primary outcome
Number of Participants With Progression Free Survival
Time frame: Up to 60 months
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2021.
- Derived from this study: PubMed 32721955Kjellman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
25 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroenteropancreatic Neuroendocrine Tumors, run by Ipsen at 25 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Sweden, Lithuania, Norway, Denmark, Finland and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Progression Free Survival (time frame: Up to 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02630654, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2021.