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

New Onset of DiabetEs in aSsociation With Pancreatic Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2; Diabetes Mellitus; Diabetes; Pancreatic Cancer; Diabetes type2; Pancreas Adenocarcinoma; Cancer of Pancreas; Pancreas Neoplasm

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 2522

Contacts and Locations

• Study Contact: Name: Dóra Illés, MD; Phone Number: +36 20 232 93 65; Email: olionx@gmail.com
• Study Contact Backup: Name: László Czakó, MD, PhD, DSc; Phone Number: +36 20 331 5645; Email: czako.laszlo@med.u-szeged.hu

Study Locations

• Hungary
  • Csongrád
    • Szeged, Csongrád, Hungary, 6725
      • Recruiting
      • First Department of Medicine, Albert Szent-Györgyi Medical and Pharmaceutical Centre, University of Szeged

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All the patients who meet the inclusion criteria will be included in the study at the participating centers at the Diabetology of the specialized outpatient clinics and also the GP practices involved.

Patients, regardless of their gender as the daily patient population over 60 years of age and diagnosed with diabetes within 6 months.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
elderly patients with newly diagnosed diabetes; Group with exposure: patients over 60 years of age with diabetes diagnosed within six months (newly diagnosed); Control Group: without exposure; patients over 60 years, without diabetes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
the proportion of localised and resectable pancreatic ductal adenocarcinoma	Will be appraised after collecting and summarizing all the collected medical information.	36 months
change in body weight	Measuring the body weight of the patient and the data is recorded in the questionaire.	36 months
Change in fasting blood glucose and HbA1c	Based on the laboratory measurements.	36 months
Antidiabetic medications and the risk of pancreatic ductal adenocarcinoma	According to the anwers of the patients recorded on the questionnaire.	36 months
presence of concomitant diseases	According to the physical examinations and laboratory parameters also the anwers of the patients recorded on the questionnaire	36 months
smoking and alcohol intake	According to the anwers of the patients recorded on the questionnaire.	36 months
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
Cost-benefit analysis	Healthcare cost spent on each patient will be calculated by a healthcare economist after the trial is completed.	36 months

Collaborators and Investigators

• Sponsor: University of Pecs
• Collaborators: Hungarian Pancreatic Study Group (HPSG)
• Investigators: Study Chair: Péter Hegyi, MD, PhD, DSc, Insitute for Translational Medicine, Medical School, University of Pécs, HU; Principal Investigator: László Czakó, MD, PhD, DSc, First Department of Medicine University of Szeged, HU

Publications and helpful links

General Publications

• 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: 10.1158/0008-5472.CAN-14-0155. Erratum In: Cancer Res. 2014 Jul 15;74(14):4006.
• 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 risk for pancreatic cancer. Gut. 2007 Oct;56(10):1460-9. doi: 10.1136/gut.2006.108456.
• 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.
• 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.
• 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.
• 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.
• 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. Epub 2015 Dec 23.
• 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.
• 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.
• 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 ductal adenocarcinoma from chronic pancreatitis. Gut. 2018 Jan;67(1):128-137. doi: 10.1136/gutjnl-2016-312432. Epub 2017 Jan 20. Erratum In: Gut. 2018 May;67(5):994.
• Illes D, Ivany E, Holzinger G, Kosar K, Adam MG, Kamlage B, Zsori G, Tajti M, Svebis MM, Horvath V, Olah I, Marta K, Vancsa S, Zadori N, Szentesi A, Czako B, Hegyi P, Czako L. New Onset of DiabetEs in aSsociation with pancreatic ductal adenocarcinoma (NODES Trial): protocol of a prospective, multicentre observational trial. BMJ Open. 2020 Nov 19;10(11):e037267. doi: 10.1136/bmjopen-2020-037267.

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2019
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): June 30, 2025

Study Registration Dates

• First Submitted: November 12, 2019
• First Submitted That Met QC Criteria: November 12, 2019
• First Posted (Actual): November 15, 2019

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 18, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: biomarker; pancreatic cancer; screening; new-onset diabetes mellitus
• Additional Relevant MeSH Terms: Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Pancreatic Neoplasms
• Other Study ID Numbers: 41085-6/2019EÜIG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No