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

November 17, 2017 updated by: Laura Antolino, University of Roma La Sapienza

Role of Adrenomedullin in Early Diagnosis of Pancreatic Cancer 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.

Study Overview

Status

Terminated

Conditions

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 Type

Observational

Enrollment (Actual)

21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy, 00100
        • Università Sapienza di Roma, Azienda Ospedaliera Sant'Andrea

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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%)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
High AM
Newly diagnosed diabetic patients with high Adrenomedullin serum levels
Low AM
Newly diagnosed diabetic patients with low Adrenomedullin serum levels

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pancreatic cancer diagnosis
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Investigators

  • Principal Investigator: Laura Antolino, MD, Università Sapienza di Roma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

May 25, 2015

First Submitted That Met QC Criteria

May 27, 2015

First Posted (Estimate)

May 28, 2015

Study Record Updates

Last Update Posted (Actual)

November 20, 2017

Last Update Submitted That Met QC Criteria

November 17, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3463_2014_D'Angelo

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe