Identification of Biomarker Profiles GEP-NEN Patients

Neuroendocrine Tumors Clinical Trial

Official title:

Identification of Biomarker Profiles for Individualized Prognostic Stratification and Therapy in Patients With Gastroenteropancreatic Neuroendocrine Neoplasia (GEP-NEN)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02838862
• Other study ID #: 16-087
• Status: Recruiting
• Phase: N/A
• First received: July 16, 2016
• Last updated: July 19, 2016
• Start date: July 2016
• Est. completion date: June 2017

Study information

• Verified date: July 2016
• Source: University of Schleswig-Holstein
• Contact: Franck G Billmann, MD, PhD
• Phone: +494515001917
• Email: Franck.Billmann[@]uksh.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical 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. 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?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 470
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 95 Years

Eligibility

Inclusion Criteria:

• GEP-NEN

Exclusion Criteria:

• Absence of histological confirmation of the diagnosis

• Absence of pathology specimen to evaluate using MALDI-MS

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Carcinoid Tumor
• Neuroendocrine Tumors

Locations

Country	Name	City	State
Germany	University Hospital Freiburg - Department of Surgery	Freiburg im Breisgau	Baden-Württemberg
Germany	University Hospital SH - Campus Lübeck - Department of Surgery	Lübeck	Schleswig Holstein
Germany	Agaplesion Diakonieklinikum Rotenburg - Department of Surgery	Rotenburg

Sponsors (2)

Lead Sponsor	Collaborator
University of Schleswig-Holstein	University Hospital Freiburg

Country where clinical trial is conducted

Germany, 

References & Publications (6)

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Löhr JM, Faissner R, Findeisen P, Neumaier M. [Proteome analysis--basis for individualized pancreatic carcinoma therapy?]. Internist (Berl). 2006 Jun;47 Suppl 1:S40-8. Review. German. — View Citation

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. Review. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to Therapy (Surgery, Chemotherapy, Radiotherapy, etc.)		12 months - 10 years (retrospective groups)	No
Secondary	Overall Survival		12 months - 10 years (retrospective groups)	No
Secondary	Disease free Survival		12 months - 10 years (retrospective groups)	No
Secondary	Morbidity		12 months - 10 years (retrospective groups)	No
Secondary	Mortality		12 months - 10 years (retrospective groups)	No