Ignite Creation Date:
2024-05-06 @ 2:41 AM
Last Modification Date:
2024-10-26 @ 11:22 AM
Study NCT ID:
NCT02102893
Status:
COMPLETED
Last Update Posted:
2022-07-29
First Post:
2014-02-27
Brief Title:
Gastroenteral-Pancreatic Neuroendocrine Tumors in Taiwan
Sponsor:
National Health Research Institutes Taiwan
Organization:
National Health Research Institutes Taiwan
Study Overview
Official Title:
A Multi-center Registration Study for Gastroenteral-Pancreatic Neuroendocrine Tumors in Taiwan
Status:
COMPLETED
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 03 to 151 per 100000 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 andor 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 201111 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
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:
20 OBJECTIVES
21 To establish the database for GEP-NET by register the clinical presentation diagnosis stages treatment and clinical outcome of GEP-NET patients
22 To analyze the risk and prognostic factors of GEP-NET patients 23 To make a treatment consensus for GEP-NETs
30 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
31 Inclusion Criteria 311 histologically proven GEP-NET patients according to the WHO classification in any stage
312 Signed informed consent 32 Exclusion criteria 321 patients of GEP-NET without histological proof
21 To establish the database for GEP-NET by register the clinical presentation diagnosis stages treatment and clinical outcome of GEP-NET patients
22 To analyze the risk and prognostic factors of GEP-NET patients 23 To make a treatment consensus for GEP-NETs
30 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
31 Inclusion Criteria 311 histologically proven GEP-NET patients according to the WHO classification in any stage
312 Signed informed consent 32 Exclusion criteria 321 patients of GEP-NET without histological proof
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None