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临床试验/NCT02456051
NCT02456051终止不适用

Role of Adrenomedullin in Early Diagnosis of Pancreatic Cancer in New Onset Diabetes Patients

University of Roma La Sapienza1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2015年4月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
21
试验地点
1
主要终点
Pancreatic cancer diagnosis

研究概览

简要总结

Pancreatic Cancer is a leading cause of cancer-related death. To date, only one fifth of patients at diagnosis is presented resectable because the diagnosis is often delayed making the 5-year survival of this disease globally less than 5%. An early diagnosis in these patients is currently not possible given the economic disadvantages of a population-wide screening. New evidences identify patients with new-onset diabetes as a subgroup of patients at high risk of developing this disease (RR 5:38). In a subset of these patients a mediator secreted by the tumor, the Adrenomedullin, could be responsible for the onset of diabetes. Our goal is therefore to assess the different impact of Pancreatic Cancer depending on Adrenomedullin values in patients with newly diagnosed diabetes mellitus.

详细描述

The study is defined as prospective observational. The research project involves the recruitment prospectively for all consecutive patients aged between 45 and 75 years receiving a new diagnosis of diabetes, according to the criteria established by the American Diabetes Association (ADA) (fasting glucose greater than or equal 126 mg / dl, or random blood glucose greater than or equal to 200 mg / dl, or glycated hemoglobin greater than or equal to 6.25%). The recruitment will take place at the Sant'Andrea Hospital. The suitability of a subject to be included in the study will be evaluated by medical history, physical examination and any further investigations carried out by a medical researcher of the team, according to the inclusion and exclusion criteria. The research team will be multidisciplinary, translational, composed of medical specialists belonging to the departments of General Surgery, Internal Medicine, Diabetology and Occupational Medicine. An informed consent will be mandatory for the recruitment in the study. At recruitment Adrenomedullin serum levels will be recorded along with every relevant clinical and laboratory data. An annual telephone follow-up will be applied and if necessary the patient will benefit of an outpatient examination. A sample size of 440 patients will achieve 80% power to detect a statistically significant difference. The 3 years clinical follow-up will allow the detection of symptoms and signs that could be related to the presence of a pancreatic mass (jaundice, pain, weight loss), further investigations will follow in such cases to confirm Pancreatic cancer diagnosis and proceed to the treatment.

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
45 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age between 45 and 75 years
  • •Diagnosis of diabetes mellitus made within the two years preceding the date of observation (new onset diabetes)
  • •Adherence to the study documented the voluntary signing of an informed consent
  • •Availability to follow a telephone follow-up

排除标准

  • •Remote medical history (> 2 years) positive for diabetes mellitus
  • •Previous history of malignancy
  • •Pregnancy
  • •Renal Failure
  • •Documented diabetic microangiopathy

结局指标

主要结局

Pancreatic cancer diagnosis

时间窗: 3 years

次要结局

  • Mortality(3 years)

研究者

发起方
University of Roma La Sapienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Laura Antolino

MD

University of Roma La Sapienza

研究点 (1)

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