Neuroendocrine TumorsNCT02838862
Identification of Biomarker Profiles GEP-NEN Patients
An observational study of Neuroendocrine Tumors, run by University Hospital Schleswig-Holstein at 3 sites in Germany.
Trial summary
Although gastroenteropancreatic neuroendocrine neoplasia (GEP-NEN) were considered for years as rare tumors, their incidences are increasing. Due to their potential of early metastases and their heterogenous response to therapy, these tumors are important clinical entities. Read more about this study
- Who is it for?
- Ages 12 to 95 years
- Conditions the study is for
- Neuroendocrine Tumors
- How many people
- 470 participants
- Where
- 3 sitesGermany
- Study dates
- Jul 2016to Jun 2017
- 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 12 to 95 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: GEP-NEN Patients registered in the institutional NEN Registries
Who may be able to join
- GEP-NEN
Who cannot join
- Absence of histological confirmation of the diagnosis
- Absence of pathology specimen to evaluate using MALDI-MS
Trial locations and contacts
3 sites in 1 country.
Ulrich Wellner, MD contact
Germany3 sites, 3 recruiting
- Recruiting
University Hospital Freiburg - Department of Surgery
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Oliver Thomusch, MD, Oliver.Thomusch@uniklinik-freiburg.de
- Recruiting
University Hospital SH - Campus Lübeck - Department of Surgery
Lübeck, Schleswig-Holstein, 23538
Franck Billmann, MD, PhD, +494515001917, Franck.Billmann@uksh.de
- Recruiting
Agaplesion Diakonieklinikum Rotenburg - Department of Surgery
Rotenburg (Wümme), 27356
Karl Khatib-Chahidi, MD, +494261772066, Karl.Khatib-Chahidi@diako-online.de
About this study
Official title: Identification of Biomarker Profiles for Individualized Prognostic Stratification and Therapy in Patients With Gastroenteropancreatic Neuroendocrine Neoplasia (GEP-NEN)
Although gastroenteropancreatic neuroendocrine neoplasia (GEP-NEN) were considered for years as rare tumors, their incidences are increasing. Due to their potential of early metastases and their heterogenous response to therapy, these tumors are important clinical entities. A major problem remains the impossibility to adequately predict tumors' response to treatment, precluding an individualized therapy. Further, there is no method to efficiently screen these tumors. Protein based analyses (proteomic analyses) gain in interest as methods to address this problematic.
The present study was designed to investigate epidemiologic data of patients with GEP-NEN and to answer following questions using proteomic analysis applied to existing pathology specimens (paraffin-embedded specimens, FFPE): is it possible to explore protein signatures in this type of tumors? Is the response to therapy predictable using specific protein signatures? Is the tumor's tendency to metastasize related to specific protein signatures?
Read the detailed description
Gastroenteropancreatic neuroendocrine neoplasia (GEP-NEN) were considered for years as rare tumors. In last years however, their incidences are increasing (3,65 / 100.000 / year) [Lawrence et al., 2011; Friling et al, 2014]. These tumors are important clinical entities: 1) 40-95% of tumors have metastasized at diagnosis, 2) evidence-based data dealing with the therapeutic strategy and screening are still scarce.
A central problem remains the impossibility to adequately predict the response to surgery, chemotherapy, radiochemotherapy, peptid-receptor-based Radiotherapy or biotherapy, precluding an individualized therapy (precision medicine) [Rinke et al., 2014]. An actual research topic in these patients is the identification of patient markers allowing an response prediction. Moreover, researchers try to identify tumor markers in patients with unknown primary in order to locate the origin of metastases. Further, identification of tumor specific markers would allow the development of screening strategies in GEP-NEN. Due to the ability of these techniques to describe the biological heterogenity of a tumor, proteomics (protein based analysis methods) are promising in the present problematic [Bezabeh et al., 2014; Löhr et al., 2006; Pan et al., 2013].
The present study was designed to investigate epidemiologic data of patients with GEP-NEN and to answer following questions using proteomic analysis (MALDI-MS) applied to existing pathology specimens (paraffin-embedded specimens, FFPE): is it possible to explore protein signatures in this type of tumors? Is the response to therapy predictable using specific protein signatures? Is the tumor's tendency to metastasize related to specific protein signatures? The present investigation explores the GEP-NEN database/register of following institutions: University Hospital Schleswig Holstein, University hospital of Freiburg, Agaplesion Hospital Rotenburg. The pathology specimens of the studied register-population, were identified in the biobank and pathology-institutes of the participating hospitals and investigated using MALDI-MS technique.
- Conditions
- Neuroendocrine Tumors
- Keywords
- Neuroendocrine Tumors, MALDI-MS, Proteomics, Biomarkers, Tumor, Precision Medicine
- Medical subject headings
- Neuroendocrine Tumors, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Response to Therapy | Not described | |
| No therapy response | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to Therapy (Surgery, Chemotherapy, Radiotherapy, etc.)
Measured: 12 months - 10 years (retrospective groups)
Secondary outcomes (4)
Overall Survival
Measured: 12 months - 10 years (retrospective groups)
Disease free Survival
Measured: 12 months - 10 years (retrospective groups)
Morbidity
Measured: 12 months - 10 years (retrospective groups)
Mortality
Measured: 12 months - 10 years (retrospective groups)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- 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
- Time perspective
- Retrospective
- Enrolment
- 470 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Freiburg
- Responsible party
- Principal investigator, Franck Billmann, University Hospital Schleswig-Holstein
- Investigators
- Tobias Keck, MD, PhD, Study chair, University Hospital Lübeck - Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02838862
- Sponsor's protocol ID
- 16-087
- Status last verified
- Jul 2016
- First submitted
- 16 Jul 2016
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bezabeh T, Ijare OB, Nikulin AE, Somorjai RL, Smith IC. MRS-based Metabolomics in Cancer Research. Magn Reson Insights. 2014 Feb 13;7:1-14. doi: 10.4137/MRI.S13755. eCollection 2014.
PubMed 25114549Frilling A, Modlin IM, Kidd M, Russell C, Breitenstein S, Salem R, Kwekkeboom D, Lau WY, Klersy C, Vilgrain V, Davidson B, Siegler M, Caplin M, Solcia E, Schilsky R; Working Group on Neuroendocrine Liver Metastases. Recommendations for management of patients with neuroendocrine liver metastases. Lancet Oncol. 2014 Jan;15(1):e8-21. doi: 10.1016/S1470-2045(13)70362-0.
PubMed 24384494Lawrence B, Gustafsson BI, Chan A, Svejda B, Kidd M, Modlin IM. The epidemiology of gastroenteropancreatic neuroendocrine tumors. Endocrinol Metab Clin North Am. 2011 Mar;40(1):1-18, vii. doi: 10.1016/j.ecl.2010.12.005.
PubMed 21349409Lohr JM, Faissner R, Findeisen P, Neumaier M. [Proteome analysis--basis for individualized pancreatic carcinoma therapy?]. Internist (Berl). 2006 Jun;47 Suppl 1:S40-8. doi: 10.1007/s00108-006-1634-7. German.
PubMed 16773365Pan S, Brentnall TA, Kelly K, Chen R. Tissue proteomics in pancreatic cancer study: discovery, emerging technologies, and challenges. Proteomics. 2013 Feb;13(3-4):710-21. doi: 10.1002/pmic.201200319. Epub 2013 Jan 7.
PubMed 23125171Rinke A, Arnold R. Aktuelle Therapie neuroendokriner Tumoren. Arzneimitteltherapie 2014;32:2-13
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Biomarker Profiles for Individualized Prognostic Stratification and Therapy in Patients With Gastroenteropancreatic Neuroendocrine Neoplasia (GEP-NEN)
- ClinicalTrials.gov ID
- NCT02838862
- Acronym / sponsor ID
- 16-087
- Conditions
- Neuroendocrine Tumors
- Keywords
- Neuroendocrine Tumors, MALDI-MS, Proteomics, Biomarkers, Tumor, Precision Medicine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 470 participants (estimated)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Collaborators
- University Hospital Freiburg
- Study start
- Jul 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 20 Jul 2016 (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.
Although gastroenteropancreatic neuroendocrine neoplasia (GEP-NEN) were considered for years as rare tumors, their incidences are increasing. Due to their potential of early metastases and their heterogenous response to therapy, these tumors are important clinical entities. A major problem remains the impossibility to adequately predict tumors' response to treatment, precluding an individualized therapy. Further, there is no method to efficiently screen these tumors. Protein based analyses (proteomic analyses) gain in interest as methods to address this problematic.
The present study was designed to investigate epidemiologic data of patients with GEP-NEN and to answer following questions using proteomic analysis applied to existing pathology specimens (paraffin-embedded specimens, FFPE): is it possible to explore protein signatures in this type of tumors? Is the response to therapy predictable using specific protein signatures? Is the tumor's tendency to metastasize related to specific protein signatures?
Detailed description
Gastroenteropancreatic neuroendocrine neoplasia (GEP-NEN) were considered for years as rare tumors. In last years however, their incidences are increasing (3,65 / 100.000 / year) [Lawrence et al., 2011; Friling et al, 2014]. These tumors are important clinical entities: 1) 40-95% of tumors have metastasized at diagnosis, 2) evidence-based data dealing with the therapeutic strategy and screening are still scarce.
A central problem remains the impossibility to adequately predict the response to surgery, chemotherapy, radiochemotherapy, peptid-receptor-based Radiotherapy or biotherapy, precluding an individualized therapy (precision medicine) [Rinke et al., 2014]. An actual research topic in these patients is the identification of patient markers allowing an response prediction. Moreover, researchers try to identify tumor markers in patients with unknown primary in order to locate the origin of metastases. Further, identification of tumor specific markers would allow the development of screening strategies in GEP-NEN. Due to the ability of these techniques to describe the biological heterogenity of a tumor, proteomics (protein based analysis methods) are promising in the present problematic [Bezabeh et al., 2014; Löhr et al., 2006; Pan et al., 2013].
The present study was designed to investigate epidemiologic data of patients with GEP-NEN and to answer following questions using proteomic analysis (MALDI-MS) applied to existing pathology specimens (paraffin-embedded specimens, FFPE): is it possible to explore protein signatures in this type of tumors? Is the response to therapy predictable using specific protein signatures? Is the tumor's tendency to metastasize related to specific protein signatures? The present investigation explores the GEP-NEN database/register of following institutions: University Hospital Schleswig Holstein, University hospital of Freiburg, Agaplesion Hospital Rotenburg. The pathology specimens of the studied register-population, were identified in the biobank and pathology-institutes of the participating hospitals and investigated using MALDI-MS technique.
Study design
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Response to Therapy | – | – |
| No therapy response | – | – |
Who may qualify
- Ages
- 12 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- GEP-NEN Patients registered in the institutional NEN Registries
Key inclusion criteria (1 listed)
- GEP-NEN
Key exclusion criteria (2 listed)
- Absence of histological confirmation of the diagnosis
- Absence of pathology specimen to evaluate using MALDI-MS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Response to Therapy (Surgery, Chemotherapy, Radiotherapy, etc.)
Time frame: 12 months - 10 years (retrospective groups)
4 secondary outcomes
Overall Survival
Time frame: 12 months - 10 years (retrospective groups)
Disease free Survival
Time frame: 12 months - 10 years (retrospective groups)
Morbidity
Time frame: 12 months - 10 years (retrospective groups)
Mortality
Time frame: 12 months - 10 years (retrospective groups)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2016.
- Background: PubMed 25114549Bezabeh T, Ijare OB, Nikulin AE, Somorjai RL, Smith IC. MRS-based Metabolomics in Cancer Research. Magn Reson Insights. 2014 Feb 13;7:1-14. doi: 10.4137/MRI.S13755. eCollection 2014.
- Background: PubMed 24384494Frilling A, Modlin IM, Kidd M, Russell C, Breitenstein S, Salem R, Kwekkeboom D, Lau WY, Klersy C, Vilgrain V, Davidson B, Siegler M, Caplin M, Solcia E, Schilsky R; Working Group on Neuroendocrine Liver Metastases. Recommendations for management of patients with neuroendocrine liver metastases. Lancet Oncol. 2014 Jan;15(1):e8-21. doi: 10.1016/S1470-2045(13)70362-0.
- Background: PubMed 21349409Lawrence B, Gustafsson BI, Chan A, Svejda B, Kidd M, Modlin IM. The epidemiology of gastroenteropancreatic neuroendocrine tumors. Endocrinol Metab Clin North Am. 2011 Mar;40(1):1-18, vii. doi: 10.1016/j.ecl.2010.12.005.
- Background: PubMed 16773365Lohr JM, Faissner R, Findeisen P, Neumaier M. [Proteome analysis--basis for individualized pancreatic carcinoma therapy?]. Internist (Berl). 2006 Jun;47 Suppl 1:S40-8. doi: 10.1007/s00108-006-1634-7. German.
- Background: PubMed 23125171Pan S, Brentnall TA, Kelly K, Chen R. Tissue proteomics in pancreatic cancer study: discovery, emerging technologies, and challenges. Proteomics. 2013 Feb;13(3-4):710-21. doi: 10.1002/pmic.201200319. Epub 2013 Jan 7.
- BackgroundRinke A, Arnold R. Aktuelle Therapie neuroendokriner Tumoren. Arzneimitteltherapie 2014;32:2-13
- Individual participant dataSharing planned: No
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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.
Ulrich Wellner, MD contact
Tobias Keck, MD, PhD study chair
University Hospital Lübeck - Department of Surgery
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroendocrine Tumors, run by University Hospital Schleswig-Holstein at 3 sites in Germany.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 20 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Franck G Billmann, MD, PhD (+494515001917, Franck.Billmann@uksh.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to Therapy (Surgery, Chemotherapy, Radiotherapy, etc.) (time frame: 12 months - 10 years (retrospective groups)). 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 NCT02838862, which also lists 6 linked publications.
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 20 Jul 2016; AzTrials last refreshed its copy on 7 Nov 2026.