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

NCT04164602 | Unknown DMC

• 1 other identifier: 41085-6/2019EÜIG
• Study Type: observational
• Target: 2,522
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

new-onset diabetes mellitus; pancreatic cancer; biomarker; screening

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• mortality of pancreatic ductal adenocarcinoma in new-onset diabetic patients

  36 months

• the proportion of localised and resectable pancreatic ductal adenocarcinoma

  36 months

• change in body weight

  36 months

• Change in fasting blood glucose and HbA1c

  36 months

• Antidiabetic medications and the risk of pancreatic ductal adenocarcinoma

  36 months

Study Arms (1)

elderly patients with newly diagnosed diabetes

1. Group with exposure: patients over 60 years of age with diabetes diagnosed within six months (newly diagnosed) 2. Control Group: without exposure; patients over 60 years, without diabetes.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• patients over 60 years of age
• diabetes diagnosed within six months (newly diagnosed)
• signed written informed consent

You may not qualify if:

• continous alcohol abuse
• chronic pancreatitis
• previous pancreas operation/pancreatectomy
• pregnancy
• present malignant disease

Sponsors & Collaborators

• University of Pecs: lead
• Hungarian Pancreatic Study Group (HPSG): collaborator

Study Sites (1)

First Department of Medicine, Albert Szent-Györgyi Medical and Pharmaceutical Centre, University of Szeged

Szeged, Csongrád megye, 6725, Hungary

RECRUITING

Related Publications (11)

• 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.

  PMID: 24840647 RESULT

• 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.

  PMID: 17872573 RESULT

• 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.

  PMID: 16083707 RESULT

• 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.

  PMID: 15886696 RESULT

• 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.

  PMID: 21458985 RESULT

• 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.

  PMID: 19111249 RESULT

• 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.

  PMID: 26777407 RESULT

• 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.

  PMID: 21654538 RESULT

• 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.

  PMID: 26492440 RESULT

• 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.

  PMID: 28108468 RESULT

• 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.

  PMID: 33444177 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

C-peptide and glutamic acid decarboxylase antibodies (GADA) will be determined to classify diabetes CA 19-9 will be taken at every 12 months Blood to biobank will be taken at every 12 months. Biomarkers will be determined comparing metabolite levels in plasma samples from patients diagnosed with pancreatic cancer and diabetic cancer-free patients.

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases

Study Officials

• Péter Hegyi, MD, PhD, DSc

  Insitute for Translational Medicine, Medical School, University of Pécs, HU

  STUDY CHAIR

• László Czakó, MD, PhD, DSc

  First Department of Medicine University of Szeged, HU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dóra Illés, MD

CONTACT

+36 20 232 93 65; olionx@gmail.com

László Czakó, MD, PhD, DSc

CONTACT

+36 20 331 5645; czako.laszlo@med.u-szeged.hu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: November 15, 2019
• Study Start: October 9, 2019
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)