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Gastroenteral-Pancreatic Neuroendocrine Tumors in Taiwan

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ClinicalTrials.gov Identifier: NCT02102893
Recruitment Status : Enrolling by invitation
First Posted : April 3, 2014
Last Update Posted : March 28, 2016
Sponsor:
Collaborators:
National Taiwan University Hospital
National Cheng-Kung University Hospital
Chang Gung Memorial Hospital
Information provided by (Responsible Party):
National Health Research Institutes, Taiwan

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. 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 600 GEP-NET patients. NET patients diagnosed after 2011.1.1 is included in this study.

Furthermore, we 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.


Condition or disease
This Study Plans to Include 600 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


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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: A Multi-center, Registration Study for Gastroenteral-Pancreatic Neuroendocrine Tumors in Taiwan
Study Start Date : March 2014
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2024





Primary Outcome Measures :
  1. To establish the database for GEP-NET by register the clinical presentation, diagnosis, stages, treatment and clinical outcome of GEP-NET patients. [ Time Frame: 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. ]
    Survival analysis will be conducted to calculate the hazard ratio of GEP-NET outcomes (overall survival, disease-free survival, disease-specific survival, and second primary) associated with potential prognostic factors. First, univariate survival analysis will be performed using Kaplan-Meier method. Those variables that are significantly (p<0.05) associated with GEP-NET outcomes will be included in the multivariable analysis using Cox proportional hazards regression model. With accrual interval of 10 years,an average follow-up of 5 years, and a median time to outcome of 5 years, the proposed sample size of 500 cases has a statistical power of 1.0 to detect a hazard ratio of 1.5 or more.


Biospecimen Retention:   Samples With DNA
Furthermore, we 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.


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02102893


Locations
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Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Health Research Institutes, Taiwan
National Taiwan University Hospital
National Cheng-Kung University Hospital
Chang Gung Memorial Hospital
Investigators
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Study Chair: Li-Tzong Chen, Ph.D. National Institute of Cancer Research

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Responsible Party: National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier: NCT02102893     History of Changes
Other Study ID Numbers: T1214
First Posted: April 3, 2014    Key Record Dates
Last Update Posted: March 28, 2016
Last Verified: March 2014
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by National Health Research Institutes, Taiwan:
for Gastroentero-Pancreatic Neuroendocrine Tumors in Taiwan
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Adenoma, Islet Cell
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Adenoma
Neoplasms, Glandular and Epithelial
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases