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

University of Pecs

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT04164602

41085-6/2019EÜIG

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,522 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2,522 participants in 1 patient group

elderly patients with newly diagnosed diabetes

Description:

1. Group with exposure: patients over 60 years of age with diabetes diagnosed within six months (newly diagnosed) 2. Control Group: without exposure; patients over 60 years, without diabetes.