Pancreatic Cancer Can be Detected by Adrenomedullin in New Onset Diabetes Patients
Pancreatic Cancer Can be Detected by Adrenomedullin in New Onset Diabetes Patients
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.
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.
Inclusion Criteria:

 -  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

 Exclusion Criteria:

 -  Remote medical history (> 2 years) positive for diabetes mellitus

 -  Previous history of malignancy

 -  Pregnancy

 -  Renal Failure

 -  Documented diabetic microangiopathy

 -  Sepsis