Clinical trial NCT02102893: Gastroenteral-Pancreatic Neuroendocrine Tumors in Taiwan
Official title: A Multi-center, Registration Study for Gastroenteral-Pancreatic Neuroendocrine Tumors in Taiwan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuroendocrine Tumors
Keywords: enroll the 600 patients in this trial
Lead sponsor: National Health Research Institutes, Taiwan
Sponsor class: OTHER
Collaborators: name: National Taiwan University Hospital
name: National Cheng-Kung University Hospital
name: Chang Gung Memorial Hospital
First posted: 2014-04-03
Enrollment: 600
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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

Brief 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

Eligibility 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

Primary outcomes:
measure: To establish the database for GEP-NET by register the clinical presentation, diagnosis, stages, treatment and clinical outcome of GEP-NET patients.
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
city: Taipei
country: Taiwan
facility: Chang-Gung Memorial Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Institute of Cancer Research
name: Li-Tzong Chen, Ph.D.
role: STUDY_CHAIR
References: