Identification of Biomarker Profiles GEP-NEN Patients

NCT ID: NCT02838862

Last Updated: 2016-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 470 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2017-06-30

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?

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

Study Design

• Study Time Perspective: RETROSPECTIVE

Study Groups

Response to Therapy

No interventions assigned to this group

No therapy response

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• GEP-NEN

Exclusion Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Freiburg

OTHER

Sponsor Role: collaborator

University Hospital Schleswig-Holstein

OTHER

Sponsor Role: lead

Responsible Party

Franck Billmann

Director Section for Endocrine Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tobias Keck, MD, PhD

Role: STUDY_CHAIR

University Hospital Lübeck - Department of Surgery

Locations

University Hospital Freiburg - Department of Surgery

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Site Status: RECRUITING

University Hospital SH - Campus Lübeck - Department of Surgery

Lübeck, Schleswig-Holstein, Germany

Site Status: RECRUITING

Agaplesion Diakonieklinikum Rotenburg - Department of Surgery

Rotenburg (Wümme), , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Franck G Billmann, MD, PhD

Role: CONTACT

Franck.Billmann@uksh.de

+494515001917

Ulrich Wellner, MD

Role: CONTACT

Ulrich.Wellner@uksh.de

Facility Contacts

Oliver Thomusch, MD

Role: primary

Oliver.Thomusch@uniklinik-freiburg.de

Franck Billmann, MD, PhD

Role: primary

Franck.Billmann@uksh.de

+494515001917

Karl Khatib-Chahidi, MD

Role: primary

Karl.Khatib-Chahidi@diako-online.de

+494261772066

References

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.

Reference Type: BACKGROUND

PMID: 25114549 (View on PubMed)

Frilling 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.

Reference Type: BACKGROUND

PMID: 24384494 (View on PubMed)

Lawrence 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.

Reference Type: BACKGROUND

PMID: 21349409 (View on PubMed)

Lohr 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.

Reference Type: BACKGROUND

PMID: 16773365 (View on PubMed)

Pan 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.

Reference Type: BACKGROUND

PMID: 23125171 (View on PubMed)

Rinke A, Arnold R. Aktuelle Therapie neuroendokriner Tumoren. Arzneimitteltherapie 2014;32:2-13

Reference Type: BACKGROUND

Other Identifiers

16-087

Identifier Type: -

Identifier Source: org_study_id