Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-01-10 @ 2:28 PM
Study NCT ID:
NCT02456051
Status:
TERMINATED
Last Update Posted:
2017-11-20
First Post:
2015-05-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pancreatic Cancer Can be Detected by Adrenomedullin in New Onset Diabetes Patients
Sponsor:
University of Roma La Sapienza
Organization:
Study Overview
Official Title:
Role of Adrenomedullin in Early Diagnosis of Pancreatic Cancer in New Onset Diabetes Patients
Status:
TERMINATED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
enrollment was terminated because of the poor recruitment rate
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PaCANOD
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: