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

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ClinicalTrials.gov Identifier: NCT02456051
Recruitment Status : Terminated (enrollment was terminated because of the poor recruitment rate)
First Posted : May 28, 2015
Last Update Posted : November 20, 2017
Sponsor:
Information provided by (Responsible Party):
Laura Antolino, University of Roma La Sapienza

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
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.

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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 : April 2015
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Pancreatic cancer diagnosis [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Mortality [ Time Frame: 3 years ]

Biospecimen Retention:   Samples Without DNA
Serum samples


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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%)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02456051


Locations
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Italy
Università Sapienza di Roma, Azienda Ospedaliera Sant'Andrea
Roma, Italy, 00100
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
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Principal Investigator: Laura Antolino, MD Università Sapienza di Roma

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Laura Antolino, MD, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT02456051     History of Changes
Other Study ID Numbers: 3463_2014_D'Angelo
First Posted: May 28, 2015    Key Record Dates
Last Update Posted: November 20, 2017
Last Verified: November 2017

Keywords provided by Laura Antolino, University of Roma La Sapienza:
Pancreatic Carcinoma
New-Onset Diabetes
Adrenomedullin
Early Diagnosis
Biological Markers

Additional relevant MeSH terms:
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Diabetes Mellitus
Pancreatic Neoplasms
Diabetes Complications
Carcinoma, Pancreatic Ductal
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Carcinoma, Ductal
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary
Adrenomedullin
Antihypertensive Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cardiotonic Agents
Vasodilator Agents