The Occurence of Pancreatic Cancer Studied in Association With Newly Diagnosed Diabetes in the Elderly

Diabetes Mellitus, Type 2 Clinical Trial

— NODES  

Official title:

New Onset of DiabetEs in aSsociation With Pancreatic Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04164602
• Other study ID #: 41085-6/2019EÜIG
• Status: Recruiting
• Start date: October 9, 2019
• Est. completion date: June 30, 2025

Study information

• Verified date: April 2023
• Source: University of Pecs
• Contact: Dóra Illés, MD
• Phone: +36 20 232 93 65
• Email: olionx[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to accomplish the early diagnosis of pancreatic cancer, in patients over 60 years of age with newly diagnosed diabetes. Only patients with type 2 diabetes are meant to be included. The early diagnosis of pancreatic cancer could be the way to enable efficient cure for the patients.

Description:

The prognosis of pancreatic cancer is extremely unpleasant, which can be characterized with a 5-year survival rate of only about 6%. The disease usually pertaining no symptoms at the early phase, this might be one of the causes why it is discovered at a relatively late, inoperable stage - in most of the cases. The success of reducing the high mortality rate of pancreatic cancer could depend on the significant development of early diagnosis and also prevention programs. As the lifetime prevalence of pancreatic cancer is only 1.39%, screening through the whole population would be extremely expensive and difficult to manage. It would be recommended for all the individuals at high risk for pancreatic cancer to be examined. Patients newly diagnosed with diabetes have an approximately 8-fold risk for developing this type of cancer, compared to the average population. In addition to this age is also known as an independent risk factor for the pancreatic cancer. Recently there has been a biomarker panel identified, which may distinguish between pancreatic cancer and chronic pancreatitis in patients, with high sensitivity and specificity. The aim of this study is to accomplish the early diagnosis of pancreatic cancer, in patients over 60 years of age with newly diagnosed diabetes mellitus using a specific biomarker panel. Only patients with type 2 diabetes are meant to be included. Diabetes is classified by determining C-peptide levels, representing the endogenous insulin synthesis, also detecting glutamic acid decarboxylase (GADA) antibodies, the autoantibody against the pancreatic islet cells. The early diagnosis of pancreatic cancer could be the way to enable efficient cure for the patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2522
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• patients over 60 years of age

• diabetes diagnosed within six months (newly diagnosed)

• signed written informed consent

Exclusion Criteria:

• continous alcohol abuse

• chronic pancreatitis

• previous pancreas operation/pancreatectomy

• pregnancy

• present malignant disease

Related Conditions & MeSH terms

• Cancer of Pancreas
• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes type2
• Pancreas Adenocarcinoma
• Pancreas Neoplasm
• Pancreatic Cancer
• Pancreatic Neoplasms

Locations

Country	Name	City	State
Hungary	First Department of Medicine, Albert Szent-Györgyi Medical and Pharmaceutical Centre, University of Szeged	Szeged	Csongrád

Sponsors (2)

Lead Sponsor	Collaborator
University of Pecs	Hungarian Pancreatic Study Group (HPSG)

Country where clinical trial is conducted

Hungary, 

References & Publications (10)

Ben Q, Xu M, Ning X, Liu J, Hong S, Huang W, Zhang H, Li Z. Diabetes mellitus and risk of pancreatic cancer: A meta-analysis of cohort studies. Eur J Cancer. 2011 Sep;47(13):1928-37. doi: 10.1016/j.ejca.2011.03.003. Epub 2011 Mar 31. — View Citation

Brand RE, Lerch MM, Rubinstein WS, Neoptolemos JP, Whitcomb DC, Hruban RH, Brentnall TA, Lynch HT, Canto MI; Participants of the Fourth International Symposium of Inherited Diseases of the Pancreas. Advances in counselling and surveillance of patients at — View Citation

Chari ST, Leibson CL, Rabe KG, Ransom J, de Andrade M, Petersen GM. Probability of pancreatic cancer following diabetes: a population-based study. Gastroenterology. 2005 Aug;129(2):504-11. doi: 10.1016/j.gastro.2005.05.007. — View Citation

Hart PA, Kamada P, Rabe KG, Srinivasan S, Basu A, Aggarwal G, Chari ST. Weight loss precedes cancer-specific symptoms in pancreatic cancer-associated diabetes mellitus. Pancreas. 2011 Jul;40(5):768-72. doi: 10.1097/MPA.0b013e318220816a. — View Citation

Huxley R, Ansary-Moghaddam A, Berrington de Gonzalez A, Barzi F, Woodward M. Type-II diabetes and pancreatic cancer: a meta-analysis of 36 studies. Br J Cancer. 2005 Jun 6;92(11):2076-83. doi: 10.1038/sj.bjc.6602619. — View Citation

Illes D, Terzin V, Holzinger G, Kosar K, Roka R, Zsori G, Abraham G, Czako L. New-onset type 2 diabetes mellitus--A high-risk group suitable for the screening of pancreatic cancer? Pancreatology. 2016 Mar-Apr;16(2):266-71. doi: 10.1016/j.pan.2015.12.005. — View Citation

Mayerle J, Kalthoff H, Reszka R, Kamlage B, Peter E, Schniewind B, Gonzalez Maldonado S, Pilarsky C, Heidecke CD, Schatz P, Distler M, Scheiber JA, Mahajan UM, Weiss FU, Grutzmann R, Lerch MM. Metabolic biomarker signature to differentiate pancreatic duct — View Citation

Munigala S, Singh A, Gelrud A, Agarwal B. Predictors for Pancreatic Cancer Diagnosis Following New-Onset Diabetes Mellitus. Clin Transl Gastroenterol. 2015 Oct 22;6(10):e118. doi: 10.1038/ctg.2015.44. — View Citation

Pannala R, Basu A, Petersen GM, Chari ST. New-onset diabetes: a potential clue to the early diagnosis of pancreatic cancer. Lancet Oncol. 2009 Jan;10(1):88-95. doi: 10.1016/S1470-2045(08)70337-1. — View Citation

Rahib L, Smith BD, Aizenberg R, Rosenzweig AB, Fleshman JM, Matrisian LM. Projecting cancer incidence and deaths to 2030: the unexpected burden of thyroid, liver, and pancreas cancers in the United States. Cancer Res. 2014 Jun 1;74(11):2913-21. doi: 10.11 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of pancreatic ductal adenocarcinoma in patients with new-onset diabetes	This will be evaluated using yes/no questions on carcinoma ductale, then the data will be summarized in order to determine the incidence.	36 months
Secondary	mortality of pancreatic ductal adenocarcinoma in new-onset diabetic patients	This will be evaluated using yes/no questions as part of a questionnaire filled out by the doctor who examines the patients.	36 months
Secondary	the proportion of localised and resectable pancreatic ductal adenocarcinoma	Will be appraised after collecting and summarizing all the collected medical information.	36 months
Secondary	change in body weight	Measuring the body weight of the patient and the data is recorded in the questionaire.	36 months
Secondary	Change in fasting blood glucose and HbA1c	Based on the laboratory measurements.	36 months
Secondary	Antidiabetic medications and the risk of pancreatic ductal adenocarcinoma	According to the anwers of the patients recorded on the questionnaire.	36 months
Secondary	presence of concomitant diseases	According to the physical examinations and laboratory parameters also the anwers of the patients recorded on the questionnaire	36 months
Secondary	smoking and alcohol intake	According to the anwers of the patients recorded on the questionnaire.	36 months
Secondary	The sensitivity, specificity, positive and negative predictive values, and accuracy of the biomarker test	Will be appraised after collecting and summarizing all the collected medical information.	36 months
Secondary	Cost-benefit analysis	Healthcare cost spent on each patient will be calculated by a healthcare economist after the trial is completed.	36 months