Gastroenteral-Pancreatic Neuroendocrine Tumors in Taiwan
Conditions
Gastroenteral-Pancreatic Neuroendocrine Tumors
Conditions: official terms
Adenoma, Islet Cell - Apudoma - Carcinoid Tumor - Neuroendocrine Tumors
Conditions: Keywords
a median time to outcome of 5 years, the proposed sample size of 500 cases has a statistical power
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Case-Only, Time Perspective: Retrospective
Overall Status
Recruiting
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 NETs incidence was 1.09 per 100,000 in 1973 and increased to 3.31 and 5.25 per 100,000 in 1993 and 2004, respectively, based on the SEER data. The NETs incidence in Norway increased from 2.35 per 100,000 during 1993-1997 to 4.06 per 100,000 during 2000-2004. 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. We suppose that this epidemiologic study would provide a database potentially to improve the diagnosis, and treatment of GEP-NET. This study plans to include 500 GEP-NET 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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 20 Years
Gender: Both
Criteria: Inclusion Criteria:

- Histologically proven GEP-NET patients, according to the WHO classification in any stage.

- Signed informed consent

Exclusion Criteria:

- Patients of GEP-NET without histological proof
Location
National Taiwan University Hospital
Taipei, Taiwan
Status: Recruiting
Contact: Hsiu-Po Wang, M.D. - 886-2-23123456 - wanghp@ntu.edu.tw
Start Date
March 2014
Completion Date
February 2024
Sponsors
National Health Research Institutes, Taiwan
Source
National Health Research Institutes, Taiwan
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page