Clinical trial NCT04164602: The Occurence of Pancreatic Cancer Studied in Association With Newly Diagnosed Diabetes in the Elderly
Official title: New Onset of DiabetEs in aSsociation With Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus
Diabetes
Diabetes Mellitus, Type 2
Diabetes type2
Cancer of Pancreas
Pancreas Neoplasm
Pancreas Adenocarcinoma
Pancreatic Cancer
Keywords: new-onset diabetes mellitus
pancreatic cancer
biomarker
screening
Lead sponsor: University of Pecs
Sponsor class: OTHER
Collaborators: name: Hungarian Pancreatic Study Group (HPSG)
First posted: 2019-11-15
Enrollment: 2522
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All the patients who meet the inclusion criteria will be included in the study at the participating centers at the Diabetology of the specialized outpatient clinics and also the GP practices involved.

Patients, regardless of their gender as the daily patient population over 60 years of age and diagnosed with diabetes within 6 months.

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.

Eligibility criteria: 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

Primary outcomes:
measure: incidence of pancreatic ductal adenocarcinoma in patients with new-onset diabetes
timeFrame: 36 months
Secondary outcomes:
measure: mortality of pancreatic ductal adenocarcinoma in new-onset diabetic patients
timeFrame: 36 months
measure: the proportion of localised and resectable pancreatic ductal adenocarcinoma
timeFrame: 36 months
measure: change in body weight
timeFrame: 36 months
measure: Change in fasting blood glucose and HbA1c
timeFrame: 36 months
measure: Antidiabetic medications and the risk of pancreatic ductal adenocarcinoma
timeFrame: 36 months
measure: presence of concomitant diseases
timeFrame: 36 months
measure: smoking and alcohol intake
timeFrame: 36 months
measure: The sensitivity, specificity, positive and negative predictive values, and accuracy of the biomarker test
timeFrame: 36 months
measure: Cost-benefit analysis
timeFrame: 36 months
Other outcomes:
Locations:
city: Szeged
country: Hungary
facility: First Department of Medicine, Albert Szent-Györgyi Medical and Pharmaceutical Centre, University of Szeged
state: Csongrád
Study officials:
affiliation: Insitute for Translational Medicine, Medical School, University of Pécs, HU
name: Péter Hegyi, MD, PhD, DSc
role: STUDY_CHAIR
affiliation: First Department of Medicine University of Szeged, HU
name: László Czakó, MD, PhD, DSc
role: PRINCIPAL_INVESTIGATOR
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