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临床试验/NCT04164602
NCT04164602招募中不适用

New Onset of DiabetEs in aSsociation With Pancreatic Cancer

University of Pecs1 个研究点 分布在 1 个国家目标入组 2,522 人开始时间: 2019年10月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
2,522
试验地点
1
主要终点
incidence of pancreatic ductal adenocarcinoma in patients with new-onset diabetes

研究概览

简要总结

The aim of this study is to accomplish the early diagnosis of pancreatic cancer, in patients over 60 years of age with newly diagnosed diabetes. Only patients with type 2 diabetes are meant to be included. The early diagnosis of pancreatic cancer could be the way to enable efficient cure for the patients.

详细描述

The prognosis of pancreatic cancer is extremely unpleasant, which can be characterized with a 5-year survival rate of only about 6%. The disease usually pertaining no symptoms at the early phase, this might be one of the causes why it is discovered at a relatively late, inoperable stage - in most of the cases. The success of reducing the high mortality rate of pancreatic cancer could depend on the significant development of early diagnosis and also prevention programs. As the lifetime prevalence of pancreatic cancer is only 1.39%, screening through the whole population would be extremely expensive and difficult to manage. It would be recommended for all the individuals at high risk for pancreatic cancer to be examined. Patients newly diagnosed with diabetes have an approximately 8-fold risk for developing this type of cancer, compared to the average population. In addition to this age is also known as an independent risk factor for the pancreatic cancer. Recently there has been a biomarker panel identified, which may distinguish between pancreatic cancer and chronic pancreatitis in patients, with high sensitivity and specificity. The aim of this study is to accomplish the early diagnosis of pancreatic cancer, in patients over 60 years of age with newly diagnosed diabetes mellitus using a specific biomarker panel. Only patients with type 2 diabetes are meant to be included. Diabetes is classified by determining C-peptide levels, representing the endogenous insulin synthesis, also detecting glutamic acid decarboxylase (GADA) antibodies, the autoantibody against the pancreatic islet cells. The early diagnosis of pancreatic cancer could be the way to enable efficient cure for the patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients over 60 years of age
  • diabetes diagnosed within six months (newly diagnosed)
  • signed written informed consent

排除标准

  • continous alcohol abuse
  • chronic pancreatitis
  • previous pancreas operation/pancreatectomy
  • pregnancy
  • present malignant disease

结局指标

主要结局

incidence of pancreatic ductal adenocarcinoma in patients with new-onset diabetes

时间窗: 36 months

This will be evaluated using yes/no questions on carcinoma ductale, then the data will be summarized in order to determine the incidence.

次要结局

  • Change in fasting blood glucose and HbA1c(36 months)
  • smoking and alcohol intake(36 months)
  • change in body weight(36 months)
  • Antidiabetic medications and the risk of pancreatic ductal adenocarcinoma(36 months)
  • the proportion of localised and resectable pancreatic ductal adenocarcinoma(36 months)
  • mortality of pancreatic ductal adenocarcinoma in new-onset diabetic patients(36 months)
  • presence of concomitant diseases(36 months)
  • Cost-benefit analysis(36 months)
  • The sensitivity, specificity, positive and negative predictive values, and accuracy of the biomarker test(36 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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