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- Klinische proef NCT02102893
Gastroenteral-Pancreatic Neuroendocrine Tumors in Taiwan
A Multi-center, Registration Study for Gastroenteral-Pancreatic Neuroendocrine Tumors in Taiwan
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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Changhua, Taiwan
- Changhua Christian Hospital
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Taipei, Taiwan
- National Taiwan University Hospital
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Taipei, Taiwan
- Chang-Gung Memorial Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
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
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Case-Alleen
- Tijdsperspectieven: Retrospectief
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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To establish the database for GEP-NET by register the clinical presentation, diagnosis, stages, treatment and clinical outcome of GEP-NET patients.
Tijdsspanne: 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.
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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.
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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.
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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- T1214
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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Klinische onderzoeken op Neuro-endocriene tumoren
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Sorrento Therapeutics, Inc.IngetrokkenVaste tumor | Recidiverende vaste tumor | Refractaire tumor
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Aadi Bioscience, Inc.WervingGeavanceerde vaste tumor | Tumor | Tumor, solideVerenigde Staten
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Memorial Sloan Kettering Cancer CenterWervingVaste tumor | Vaste tumor, volwassen | Vaste tumor, niet gespecificeerd, volwassenVerenigde Staten
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Memorial Sloan Kettering Cancer CenterLincoln Medical and Mental Health CenterWervingVaste tumor | Vaste tumor, volwassen | Vaste tumor, niet gespecificeerd, volwassenVerenigde Staten, Puerto Rico
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Memorial Sloan Kettering Cancer CenterLincoln Medical and Mental Health CenterWervingVaste tumor | Vaste tumor, volwassen | Vaste tumor, niet gespecificeerd, volwassenVerenigde Staten, Puerto Rico
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RemeGen Co., Ltd.VoltooidMetastatische vaste tumor | Lokaal geavanceerde vaste tumor | Inoperabele vaste tumorAustralië
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National Health Research Institutes, TaiwanNational Cheng-Kung University HospitalWerving
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Elpiscience Biopharma, Ltd.Shanghai Junshi Bioscience Co., Ltd.WervingNeoplasmata | Vaste tumor | Kwaadaardige tumorChina
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The First Affiliated Hospital of Xiamen UniversityWervingVaste tumor | Tumor | Positron-emissietomografieChina
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Dicerna Pharmaceuticals, Inc., a Novo Nordisk companyWervingVaste tumor, volwassen | Refractaire tumorVerenigde Staten