New Onset of DiabetEs in aSsociation with pancreatic ductal adenocarcinoma (NODES Trial): protocol of a prospective, multicentre observational trial
Introduction Pancreatic ductal adenocarcinoma (PDAC) has a dismal prognosis with an overall 5-year survival of approximately 8%. The success in reducing the mortality rate of PDAC is related to the discovery of new therapeutic agents, and to a significant extent to the development of early detection...
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BMJ Publishing Group
2020-11-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/11/e037267.full |
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| author | Péter Hegyi Andrea Szentesi Katalin Márta László Czakó Noémi Zádori Dóra Illés Emese Ivány Gábor Holzinger Klára Kosár M Gordian Adam Beate Kamlage Gábor Zsóri Máté Tajti Márk M Svébis Viktor Horváth Ilona Oláh Szilárd Váncsa Bálint Czakó |
| author_facet | Péter Hegyi Andrea Szentesi Katalin Márta László Czakó Noémi Zádori Dóra Illés Emese Ivány Gábor Holzinger Klára Kosár M Gordian Adam Beate Kamlage Gábor Zsóri Máté Tajti Márk M Svébis Viktor Horváth Ilona Oláh Szilárd Váncsa Bálint Czakó |
| author_sort | Péter Hegyi |
| collection | DOAJ |
| description | Introduction Pancreatic ductal adenocarcinoma (PDAC) has a dismal prognosis with an overall 5-year survival of approximately 8%. The success in reducing the mortality rate of PDAC is related to the discovery of new therapeutic agents, and to a significant extent to the development of early detection and prevention programmes. Patients with new-onset diabetes mellitus (DM) represent a high-risk group for PDAC as they have an eightfold higher risk of PDAC than the general population. The proposed screening programme may allow the detection of PDAC in the early, operable stage. Diagnosing more patients in the curable stage might decrease the morbidity and mortality rates of PDAC and additionally reduce the burden of the healthcare.Methods and analysis This is a prospective, multicentre observational cohort study. Patients ≥60 years old diagnosed with new-onset (≤6 months) diabetes will be included. Exclusion criteria are (1) Continuous alcohol abuse; (2) Chronic pancreatitis; (3) Previous pancreas operation/pancreatectomy; (4) Pregnancy; (5) Present malignant disease and (6) Type 1 DM. Follow-up visits are scheduled every 6 months for up to 36 months. Data collection is based on questionnaires. Clinical symptoms, body weight and fasting blood will be collected at each, carbohydrate antigen 19–9 and blood to biobank at every second visit. The blood samples will be processed to plasma and analysed with mass spectrometry (MS)-based metabolomics. The metabolomic data will be used for biomarker validation for early detection of PDAC in the high-risk group patients with new-onset diabetes. Patients with worrisome features will undergo MRI or endoscopic ultrasound investigation, and surgical referral depending on the radiological findings. One of the secondary end points is the incidence of PDAC in patients with newly diagnosed DM.Ethics and dissemination The study has been approved by the Scientific and Research Ethics Committee of the Hungarian Medical Research Council (41085-6/2019). We plan to disseminate the results to several members of the healthcare system includining medical doctors, dietitians, nurses, patients and so on. We plan to publish the results in a peer-reviewed high-quality journal for professionals. In addition, we also plan to publish it for lay readers in order to maximalise the dissemination and benefits of this trial.Trial registration number ClinicalTrials.gov NCT04164602 |
| format | Article |
| id | doaj-art-a8d362cf0d2e4a23b7a712e1e28c92ee |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-11-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-a8d362cf0d2e4a23b7a712e1e28c92ee2025-08-20T02:27:10ZengBMJ Publishing GroupBMJ Open2044-60552020-11-01101110.1136/bmjopen-2020-037267New Onset of DiabetEs in aSsociation with pancreatic ductal adenocarcinoma (NODES Trial): protocol of a prospective, multicentre observational trialPéter Hegyi0Andrea Szentesi1Katalin Márta2László Czakó3Noémi Zádori4Dóra Illés5Emese Ivány6Gábor Holzinger7Klára Kosár8M Gordian Adam9Beate Kamlage10Gábor Zsóri11Máté Tajti12Márk M Svébis13Viktor Horváth14Ilona Oláh15Szilárd Váncsa16Bálint Czakó172 Centre for Translational Medicine, Semmelweis University, Budapest, HungaryInstitute for Translational Medicine, Medical School, University of Pécs, Pécs, HungaryInstitute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary6 First Department of Medicine, University of Szeged, Szeged, Hungary2 Institute for Translational Medicine, Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar, Pecs, HungaryFaculty of Medicine, First Department of Medicine, University of Szeged, Szeged, HungaryFirst Department of Medicine, University of Szeged Faculty of Medicine, Szeged, HungaryFirst Department of Medicine, University of Szeged Faculty of Medicine, Szeged, HungaryFirst Department of Medicine, University of Szeged Faculty of Medicine, Szeged, HungaryTegeler Weg 33, 10589, Metanomics Health GmbH, Berlin, GermanyTegeler Weg 33, 10589, Metanomics Health GmbH, Berlin, GermanyFirst Department of Medicine, University of Szeged Faculty of Medicine, Szeged, HungaryFirst Department of Medicine, University of Szeged Faculty of Medicine, Szeged, HungaryDepartment of Internal Medicine, Semmelweis University of Medicine, Budapest, HungaryDepartment of Internal Medicine, Semmelweis University of Medicine, Budapest, HungaryIlona Tóth Outpatient Clinic, Budapest, HungaryCentre for Translational Medicine, Semmelweis University, Budapest, HungaryMedical School, University of Szeged Faculty of Medicine, Szeged, HungaryIntroduction Pancreatic ductal adenocarcinoma (PDAC) has a dismal prognosis with an overall 5-year survival of approximately 8%. The success in reducing the mortality rate of PDAC is related to the discovery of new therapeutic agents, and to a significant extent to the development of early detection and prevention programmes. Patients with new-onset diabetes mellitus (DM) represent a high-risk group for PDAC as they have an eightfold higher risk of PDAC than the general population. The proposed screening programme may allow the detection of PDAC in the early, operable stage. Diagnosing more patients in the curable stage might decrease the morbidity and mortality rates of PDAC and additionally reduce the burden of the healthcare.Methods and analysis This is a prospective, multicentre observational cohort study. Patients ≥60 years old diagnosed with new-onset (≤6 months) diabetes will be included. Exclusion criteria are (1) Continuous alcohol abuse; (2) Chronic pancreatitis; (3) Previous pancreas operation/pancreatectomy; (4) Pregnancy; (5) Present malignant disease and (6) Type 1 DM. Follow-up visits are scheduled every 6 months for up to 36 months. Data collection is based on questionnaires. Clinical symptoms, body weight and fasting blood will be collected at each, carbohydrate antigen 19–9 and blood to biobank at every second visit. The blood samples will be processed to plasma and analysed with mass spectrometry (MS)-based metabolomics. The metabolomic data will be used for biomarker validation for early detection of PDAC in the high-risk group patients with new-onset diabetes. Patients with worrisome features will undergo MRI or endoscopic ultrasound investigation, and surgical referral depending on the radiological findings. One of the secondary end points is the incidence of PDAC in patients with newly diagnosed DM.Ethics and dissemination The study has been approved by the Scientific and Research Ethics Committee of the Hungarian Medical Research Council (41085-6/2019). We plan to disseminate the results to several members of the healthcare system includining medical doctors, dietitians, nurses, patients and so on. We plan to publish the results in a peer-reviewed high-quality journal for professionals. In addition, we also plan to publish it for lay readers in order to maximalise the dissemination and benefits of this trial.Trial registration number ClinicalTrials.gov NCT04164602https://bmjopen.bmj.com/content/10/11/e037267.full |
| spellingShingle | Péter Hegyi Andrea Szentesi Katalin Márta László Czakó Noémi Zádori Dóra Illés Emese Ivány Gábor Holzinger Klára Kosár M Gordian Adam Beate Kamlage Gábor Zsóri Máté Tajti Márk M Svébis Viktor Horváth Ilona Oláh Szilárd Váncsa Bálint Czakó New Onset of DiabetEs in aSsociation with pancreatic ductal adenocarcinoma (NODES Trial): protocol of a prospective, multicentre observational trial BMJ Open |
| title | New Onset of DiabetEs in aSsociation with pancreatic ductal adenocarcinoma (NODES Trial): protocol of a prospective, multicentre observational trial |
| title_full | New Onset of DiabetEs in aSsociation with pancreatic ductal adenocarcinoma (NODES Trial): protocol of a prospective, multicentre observational trial |
| title_fullStr | New Onset of DiabetEs in aSsociation with pancreatic ductal adenocarcinoma (NODES Trial): protocol of a prospective, multicentre observational trial |
| title_full_unstemmed | New Onset of DiabetEs in aSsociation with pancreatic ductal adenocarcinoma (NODES Trial): protocol of a prospective, multicentre observational trial |
| title_short | New Onset of DiabetEs in aSsociation with pancreatic ductal adenocarcinoma (NODES Trial): protocol of a prospective, multicentre observational trial |
| title_sort | new onset of diabetes in association with pancreatic ductal adenocarcinoma nodes trial protocol of a prospective multicentre observational trial |
| url | https://bmjopen.bmj.com/content/10/11/e037267.full |
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