The Occurence of Pancreatic Cancer Studied in Association With Newly Diagnosed Diabetes in the Elderly

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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New Onset of DiabetEs in aSsociation With Pancreatic Cancer

Conditions
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Pancreas Neoplasm, Diabetes Mellitus, Diabetes, Diabetes Mellitus, Type 2, Diabetes type2, Cancer of Pancreas, Pancreas Adenocarcinoma, Pancreatic Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients over 60 years of age diabetes diagnosed within six months (newly diagnosed) signed written informed consent Exclusion Criteria: continous alcohol abuse chronic pancreatitis previous pancreas operation/pancreatectomy pregnancy present malignant disease

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| elderly patients with newly diagnosed diabetes<br>Group with exposure: patients over 60 years of age with diabetes diagnosed within six months (newly diagnosed) Control Group: without exposure; patients over 60 years, without diabetes. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of pancreatic ductal adenocarcinoma in patients with new-onset diabetes | This will be evaluated using yes/no questions on carcinoma ductale, then the data will be summarized in order to determine the incidence. | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality of pancreatic ductal adenocarcinoma in new-onset diabetic patients | This will be evaluated using yes/no questions as part of a questionnaire filled out by the doctor who examines the patients. | 36 months | 
| the proportion of localised and resectable pancreatic ductal adenocarcinoma | Will be appraised after collecting and summarizing all the collected medical information. | 36 months | 
| change in body weight | Measuring the body weight of the patient and the data is recorded in the questionaire. | 36 months | 
| Change in fasting blood glucose and HbA1c | Based on the laboratory measurements. | 36 months | 
| Antidiabetic medications and the risk of pancreatic ductal adenocarcinoma | According to the anwers of the patients recorded on the questionnaire. | 36 months | 
| presence of concomitant diseases | According to the physical examinations and laboratory parameters also the anwers of the patients recorded on the questionnaire | 36 months | 
| smoking and alcohol intake | According to the anwers of the patients recorded on the questionnaire. | 36 months | 
| The sensitivity, specificity, positive and negative predictive values, and accuracy of the biomarker test | Will be appraised after collecting and summarizing all the collected medical information. | 36 months | 
| Cost-benefit analysis | Healthcare cost spent on each patient will be calculated by a healthcare economist after the trial is completed. | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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new-onset diabetes mellitus, pancreatic cancer, biomarker, screening