Clinical trial NCT02456051: Pancreatic Cancer Can be Detected by Adrenomedullin in New Onset Diabetes Patients
Official title: Role of Adrenomedullin in Early Diagnosis of Pancreatic Cancer in New Onset Diabetes Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Diabetes Mellitus, Adult-Onset
Diabetes Complications
Carcinoma, Pancreatic Ductal
Pancreatic Neoplasm
Keywords: Pancreatic Carcinoma
New-Onset Diabetes
Adrenomedullin
Early Diagnosis
Biological Markers
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2015-05-28
Enrollment: 21
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients newly diagnosed of diabetes, according to the criteria established by the American Diabetes Association (ADA) (fasting glucose greater than or equal to 126 mg/dl, or random blood glucose greater than or equal to 200 mg/dl, or glycated hemoglobin greater than or equal to 6.5%)

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pancreatic cancer diagnosis
timeFrame: 3 years
Secondary outcomes:
measure: Mortality
timeFrame: 3 years
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Università Sapienza di Roma, Azienda Ospedaliera Sant'Andrea
Study officials:
affiliation: Università Sapienza di Roma
name: Laura Antolino, MD
role: PRINCIPAL_INVESTIGATOR
References:
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