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Identification of Biomarker Profiles GEP-NEN Patients

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ClinicalTrials.gov Identifier: NCT02838862
Recruitment Status : Unknown
Verified July 2016 by Franck Billmann, University of Schleswig-Holstein.
Recruitment status was:  Recruiting
First Posted : July 20, 2016
Last Update Posted : July 20, 2016
Sponsor:
Collaborator:
University Hospital Freiburg
Information provided by (Responsible Party):
Franck Billmann, University of Schleswig-Holstein

Brief 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. 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?


Condition or disease
Neuroendocrine Tumors

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.


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Study Type : Observational
Estimated Enrollment : 470 participants
Time Perspective: Retrospective
Official Title: Identification of Biomarker Profiles for Individualized Prognostic Stratification and Therapy in Patients With Gastroenteropancreatic Neuroendocrine Neoplasia (GEP-NEN)
Study Start Date : July 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Group/Cohort
Response to Therapy
No therapy response



Primary Outcome Measures :
  1. Response to Therapy (Surgery, Chemotherapy, Radiotherapy, etc.) [ Time Frame: 12 months - 10 years (retrospective groups) ]

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 12 months - 10 years (retrospective groups) ]
  2. Disease free Survival [ Time Frame: 12 months - 10 years (retrospective groups) ]
  3. Morbidity [ Time Frame: 12 months - 10 years (retrospective groups) ]
  4. Mortality [ Time Frame: 12 months - 10 years (retrospective groups) ]

Biospecimen Retention:   Samples Without DNA
proteomic analysis (MALDI-MS) applied to existing pathology specimens of Neuroendocrine tumors (paraffin-embedded specimens, FFPE).


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Ages Eligible for Study:   12 Years to 95 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
GEP-NEN Patients registered in the institutional NEN Registries
Criteria

Inclusion Criteria:

  • GEP-NEN

Exclusion Criteria:

  • Absence of histological confirmation of the diagnosis
  • Absence of pathology specimen to evaluate using MALDI-MS

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): NCT02838862


Contacts
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Contact: Franck G Billmann, MD, PhD +494515001917 Franck.Billmann@uksh.de
Contact: Ulrich Wellner, MD Ulrich.Wellner@uksh.de

Locations
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Germany
University Hospital Freiburg - Department of Surgery Recruiting
Freiburg im Breisgau, Baden-Württemberg, Germany, 79106
Contact: Oliver Thomusch, MD       Oliver.Thomusch@uniklinik-freiburg.de   
University Hospital SH - Campus Lübeck - Department of Surgery Recruiting
Lübeck, Schleswig Holstein, Germany, 23538
Contact: Franck Billmann, MD, PhD    +494515001917    Franck.Billmann@uksh.de   
Agaplesion Diakonieklinikum Rotenburg - Department of Surgery Recruiting
Rotenburg, Germany, 27356
Contact: Karl Khatib-Chahidi, MD    +494261772066    Karl.Khatib-Chahidi@diako-online.de   
Sponsors and Collaborators
University of Schleswig-Holstein
University Hospital Freiburg
Investigators
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Study Chair: Tobias Keck, MD, PhD University Hospital Lübeck - Department of Surgery

Publications:
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Responsible Party: Franck Billmann, Director Section for Endocrine Surgery, University of Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT02838862     History of Changes
Other Study ID Numbers: 16-087
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: July 20, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Franck Billmann, University of Schleswig-Holstein:
Neuroendocrine Tumors
MALDI-MS
Proteomics
Biomarkers, Tumor
Precision Medicine

Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue