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Diabetes MellitusNODESNCT04164602

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

An observational study of Diabetes Mellitus and Diabetes, run by University of Pecs at 1 site in Hungary.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 60 years and older
How many people
2,522 participants
Where
1 siteHungary
Study dates
9 Oct 2019to 30 Jun 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

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

Hungary1 site, 1 recruiting

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

    Szeged, Csongrád megye, 6725

    Recruiting

Other trials in Hungary

About this study

Official title: 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.

Read the 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.

Keywords
new-onset diabetes mellitus, pancreatic cancer, biomarker, screening
Medical subject headings
Diabetes Mellitus, Diabetes Mellitus, Type 2, Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04164602
Study groupRoleWhat they receive
elderly patients with newly diagnosed diabetes1. 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 36 months

Secondary outcomes (9)

  1. 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.

    Measured: 36 months

  2. the proportion of localised and resectable pancreatic ductal adenocarcinoma

    Will be appraised after collecting and summarizing all the collected medical information.

    Measured: 36 months

  3. change in body weight

    Measuring the body weight of the patient and the data is recorded in the questionaire.

    Measured: 36 months

  4. Change in fasting blood glucose and HbA1c

    Based on the laboratory measurements.

    Measured: 36 months

  5. Antidiabetic medications and the risk of pancreatic ductal adenocarcinoma

    According to the anwers of the patients recorded on the questionnaire.

    Measured: 36 months

  6. presence of concomitant diseases

    According to the physical examinations and laboratory parameters also the anwers of the patients recorded on the questionnaire

    Measured: 36 months

  7. smoking and alcohol intake

    According to the anwers of the patients recorded on the questionnaire.

    Measured: 36 months

  8. 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.

    Measured: 36 months

  9. Cost-benefit analysis

    Healthcare cost spent on each patient will be calculated by a healthcare economist after the trial is completed.

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2019
  2. Study start9 Oct 2019
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion30 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,522 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04164602
Sponsor's protocol ID
41085-6/2019EÜIG
Acronym
NODES
Status last verified
Apr 2023
First submitted
12 Nov 2019
Last updated
19 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 24840647

  • 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.

    PubMed 17872573

  • 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.

    PubMed 16083707

  • 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.

    PubMed 15886696

  • 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.

    PubMed 21458985

  • 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.

    PubMed 19111249

  • 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.

    PubMed 26777407

  • 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.

    PubMed 21654538

  • 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.

    PubMed 26492440

  • 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.

    PubMed 28108468

  • 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.

    PubMed 33444177

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus and Diabetes, run by University of Pecs at 1 site in Hungary.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Dóra Illés, MD (+36 20 232 93 65, olionx@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

incidence of pancreatic ductal adenocarcinoma in patients with new-onset diabetes (time frame: 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04164602, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023.

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