Gastroenteral-Pancreatic Neuroendocrine Tumors in Taiwan
Condition: Neuroendocrine Tumors
MeSH terms: Neuroendocrine Tumors
Study type: Observational

Summary: 
      Neuroendocrine tumors (NETs) are neoplasms originating from neuroendocrine cells located
      throughout the body. They secret various peptides and cause various symptoms (carcinoid
      syndrome) or not. The incidence of NETs was not well-known till recently when Yao et al. and
      Hausa et al. published their surveys of NETs using data from the US Surveillance,
      Epidemiology, and End Results (SEER) program and from the Norwegian Registry of Cancer (NRC).
      The incidence of NETs in Taiwan by using the Taiwan Cancer Registry (TCR) data was increased
      from 0.3 to 1.51 per 100,000 from 1996 to 2008. The increased incidence for NET worldwide
      probably was partially due to the awareness and improvement of diagnostic technology.
      Compared with the incidence in western countries, the incidence of NET is much lower in
      Taiwan. And the incidence of NETs in Asian Pacific Islanders was also lower than the whites
      and blacks in US. Gastroenteral-pancreatic NETs (GEP-NETs), accounting for half to two thirds
      of all NETs, is the most common site of NETs. As the progress in the understanding of
      pathophysiology for GEP-NET, there are two novel targeted agents shown to be effective for
      the treatment of GEP-NET. Meanwhile, response to mTOR inhibitor was better for Asian than
      Caucasian in the phase III study using everolimus for advanced pancreatic NETs. These
      information suggests that there is racial difference for either genetic or environmental risk
      factors and these factors result in different incidence and/or clinical outcome. Currently,
      there is limited data for thorough epidemiologic study in Taiwan. The aim of this study is to
      collect clinical information for GEP-NET, and survey the prognostic factors for GEP-NET in
      Taiwan. the investigators suppose that this epidemiologic study would provide a database
      potentially to improve the diagnosis, and treatment of GEP-NET. This study plans to include
      600 GEP-NET patients. NET patients diagnosed after 2011.1.1 is included in this study.

      Furthermore, the investigators will provide the check of immunohistochemical staining for the
      tumor tissue of GEP-NET patients, including the functioning status (insulinoma, glucagonoma,
      gastrinoma, VIPoma) and the degree of differentiation, the expression of SSTR2 or SSTR5 and
      the check of possible primary site for unknown primary NET patients. This examination will
      provide more accurate diagnosis for the patients and further treatment suggestion for the
      patients.
    

Detailed description: 
      2.0 OBJECTIVES

      2.1 To establish the database for GEP-NET by register the clinical presentation, diagnosis,
      stages, treatment and clinical outcome of GEP-NET patients.

      2.2 To analyze the risk and prognostic factors of GEP-NET patients. 2.3 To make a treatment
      consensus for GEP-NETs

      3.0 PATIENT POPULATION There are approximately 500 patients estimated to meet the inclusion
      criteria from 10 hospitals in Taiwan. This recruitment estimate may vary and will be flexible
      since no formal sample size is required.

      3.1 Inclusion Criteria: 3.1.1 histologically proven GEP-NET patients, according to the WHO
      classification in any stage.

      3.1.2 Signed informed consent 3.2 Exclusion criteria: 3.2.1 patients of GEP-NET without
      histological proof
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        2.1 To establish the database for GEP-NET by register the clinical presentation, diagnosis,
        stages, treatment and clinical outcome of GEP-NET patients.

        2.2 To analyze the risk and prognostic factors of GEP-NET patients. 2.3 To make a treatment
        consensus for GEP-NETs
      
Biospecimen description: 
      Furthermore, the investigators will provide the check of immunohistochemical staining for the
      tumor tissue of GEP-NET patients, including the functioning status (insulinoma, glucagonoma,
      gastrinoma, VIPoma) and the degree of differentiation, the expression of SSTR2 or SSTR5 and
      the check of possible primary site for unknown primary NET patients. This examination will
      provide more accurate diagnosis for the patients and further treatment suggestion for the
      patients.
    
Keywords: enroll the 600 patients in this trial