PaCANOD: Pancreatic Cancer Can be Detected by Adrenomedullin in New Onset Diabetes Patients

Sponsor

University of Roma La Sapienza (Other)

Overall Status

Terminated

CT.gov ID

NCT02456051

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Adult-Onset Diabetes Complications Carcinoma, Pancreatic Ductal Pancreatic Neoplasm

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.

Study Design

Study Type:

Observational

Actual Enrollment :

21 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Role of Adrenomedullin in Early Diagnosis of Pancreatic Cancer in New Onset Diabetes Patients

Actual Study Start Date :

Apr 1, 2015

Actual Primary Completion Date :

Nov 1, 2017

Actual Study Completion Date :

Nov 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
High AM Newly diagnosed diabetic patients with high Adrenomedullin serum levels
Low AM Newly diagnosed diabetic patients with low Adrenomedullin serum levels

Outcome Measures

Primary Outcome Measures

Pancreatic cancer diagnosis [3 years]

Secondary Outcome Measures

Mortality [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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