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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.

Studieöversikt

Status

Avslutad

Detaljerad beskrivning

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

Studietyp

Observationell

Inskrivning (Faktisk)

600

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • Changhua, Taiwan
        • Changhua Christian Hospital
      • Taipei, Taiwan
        • National Taiwan University Hospital
      • Taipei, Taiwan
        • Chang-Gung Memorial Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

20 år till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: Endast fall
  • Tidsperspektiv: Retrospektiv

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
To establish the database for GEP-NET by register the clinical presentation, diagnosis, stages, treatment and clinical outcome of GEP-NET patients.
Tidsram: 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.
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.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

13 februari 2014

Primärt slutförande (Faktisk)

15 april 2020

Avslutad studie (Faktisk)

15 april 2020

Studieregistreringsdatum

Först inskickad

27 februari 2014

Först inskickad som uppfyllde QC-kriterierna

2 april 2014

Första postat (Uppskatta)

3 april 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

29 juli 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

27 juli 2022

Senast verifierad

1 september 2015

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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