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

Recruiting

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

• Registration Number: NCT04164602
• Lead Sponsor: University of Pecs

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-10-09
• Study First Submitted: 2019-11-12
• Study First Submitted QC: 2019-11-12
• Study First Posted: 2019-11-15
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-18
• Last Update Posted: 2023-04-19
• Primary Completion: 2024-12-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2522

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
incidence of pancreatic ductal adenocarcinoma in patients with new-onset diabetes	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

First Department of Medicine, Albert Szent-Györgyi Medical and Pharmaceutical Centre, University of Szeged; 🇭🇺 Szeged, Csongrád, Hungary