Identification of Biomarker Profiles GEP-NEN Patients

NCT02838862 | Unknown

• 1 other identifier: 16-087
• Study Type: observational
• Target: 470
• Locations: 1 country
• Sites: 3

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?

Conditions

Neuroendocrine Tumors

Keywords

Neuroendocrine Tumors; MALDI-MS; Proteomics; Biomarkers, Tumor; Precision Medicine

Outcome Measures

Primary Outcomes (1)

• Response to Therapy (Surgery, Chemotherapy, Radiotherapy, etc.)

  12 months - 10 years (retrospective groups)

Secondary Outcomes (4)

• Overall Survival

  12 months - 10 years (retrospective groups)

• Disease free Survival

  12 months - 10 years (retrospective groups)

• Morbidity

  12 months - 10 years (retrospective groups)

• Mortality

  12 months - 10 years (retrospective groups)

Study Arms (2)

Response to Therapy

No therapy response

Eligibility Criteria

• Age: 12 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

GEP-NEN Patients registered in the institutional NEN Registries

You may qualify if:

• GEP-NEN

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead
• University Hospital Freiburg: collaborator

Study Sites (3)

University Hospital Freiburg - Department of Surgery

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

RECRUITING

University Hospital SH - Campus Lübeck - Department of Surgery

Lübeck, Schleswig-Holstein, 23538, Germany

RECRUITING

Agaplesion Diakonieklinikum Rotenburg - Department of Surgery

Rotenburg (Wümme), 27356, Germany

RECRUITING

Related 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.

  PMID: 25114549 BACKGROUND

• 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.

  PMID: 24384494 BACKGROUND

• 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.

  PMID: 21349409 BACKGROUND

• 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.

  PMID: 16773365 BACKGROUND

• 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.

  PMID: 23125171 BACKGROUND

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

  BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

proteomic analysis (MALDI-MS) applied to existing pathology specimens of Neuroendocrine tumors (paraffin-embedded specimens, FFPE).

MeSH Terms

Conditions

Neuroendocrine Tumors; Neoplasms

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue

Study Officials

• Tobias Keck, MD, PhD

  University Hospital Lübeck - Department of Surgery

  STUDY CHAIR

Central Study Contacts

Franck G Billmann, MD, PhD

CONTACT

+494515001917; Franck.Billmann@uksh.de

Ulrich Wellner, MD

CONTACT

Ulrich.Wellner@uksh.de

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Section for Endocrine Surgery

Study Record Dates

• First Submitted: July 16, 2016
• First Posted: July 20, 2016
• Study Start: July 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: July 20, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)