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BMJ Open Is Committed to Open Peer Review. As Part of This Commitment We Make the Peer Review History of Every Article We Publish Publicly Available BMJ Open: first published as 10.1136/bmjopen-2020-037267 on 19 November 2020. Downloaded from BMJ Open is committed to open peer review. As part of this commitment we make the peer review history of every article we publish publicly available. When an article is published we post the peer reviewers’ comments and the authors’ responses online. We also post the versions of the paper that were used during peer review. These are the versions that the peer review comments apply to. The versions of the paper that follow are the versions that were submitted during the peer review process. They are not the versions of record or the final published versions. They should not be cited or distributed as the published version of this manuscript. BMJ Open is an open access journal and the full, final, typeset and author-corrected version of record of the manuscript is available on our site with no access controls, subscription charges or pay-per-view fees (http://bmjopen.bmj.com). If you have any questions on BMJ Open’s open peer review process please email [email protected] http://bmjopen.bmj.com/ on September 24, 2021 by guest. Protected copyright. BMJ Open BMJ Open: first published as 10.1136/bmjopen-2020-037267 on 19 November 2020. Downloaded from New Onset of DiabetEs in aSsociacion with pancreatic cancer (NODES trial): Protocol of a Prospective, Multicentre Observational trial ForJournal: peerBMJ Open review only Manuscript ID bmjopen-2020-037267 Article Type: Protocol Date Submitted by the 29-Jan-2020 Author: Complete List of Authors: Illés, Dóra; University of Szeged Faculty of Medicine, First Department of Medicine Ivány, Emese ; University of Szeged Faculty of Medicine, First Department of Medicine Holzinger, Gábor; University of Szeged Faculty of Medicine, First Department of Medicine Kosár, Klára; University of Szeged Faculty of Medicine, First Department of Medicine Volosinovszki, Hajnalka; University of Szeged Faculty of Medicine, First Department of Medicine Gordian, Adam M.; Metanomics Health GmbH Kamlage, Beate; Metanomics Health GmbH Zsóri, Gábor; University of Szeged Faculty of Medicine, First Department http://bmjopen.bmj.com/ of Medicine Tajti, Máté; University of Szeged Faculty of Medicine, First Department of Medicine Svébis, Márk ; Semmelweis University of Medicine, 1. Department of Internal Medicine Horváth, Viktor; Semmelweis University of Medicine, 1. Department of Internal Medicine Oláh, Ilona; Ilona Tóth Outpatient Clinic Márta, Katalin; Institute for Translational Medicine, University of Pécs Medical School, ; János Szentágothai Research Center, University of on September 24, 2021 by guest. Protected copyright. Pécs, Antal, Judit; Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar, Institute for Translational Medicine Zádori, Noémi; Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar, Institute for Translational Medicine Szentesi, Andrea; Pecsi Tudomanyegyetem, Institute for Translational Medicine; Szegedi Tudomanyegyetem, MTA-SZTE Translational Gastroenterology Research Group Hegyi, Péter; Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar, Institution for Translational Medicine Czakó, László; University of Szeged, First Department of Medicine General diabetes < DIABETES & ENDOCRINOLOGY, Pancreatic disease < Keywords: GASTROENTEROLOGY, PREVENTIVE MEDICINE, Protocols & guidelines < HEALTH SERVICES ADMINISTRATION & MANAGEMENT For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 1 of 18 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2020-037267 on 19 November 2020. 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Where the Submitting Author wishes to make the Work available on an Open Access basis (and 21 intends to pay the relevant APC), the terms of reuse of such Open Access shall be governed by a Creative 22 Commons licence – details of these licences and which Creative Commons licence will apply to this Work are set 23 out in our licence referred to above. 24 25 Other than as permitted in any relevant BMJ Author’s Self Archiving Policies, I confirm this Work has not been 26 accepted for publication elsewhere, is not being considered for publication elsewhere and does not duplicate 27 material already published. I confirm all authors consent to publication of this Work and authorise the granting 28 of this licence. 29 30 31 32 33 34 35 36 37 http://bmjopen.bmj.com/ 38 39 40 41 42 43 44 45 on September 24, 2021 by guest. Protected copyright. 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 3 of 18 BMJ Open 1 2 3 BMJ Open: first published as 10.1136/bmjopen-2020-037267 on 19 November 2020. Downloaded from 4 5 6 New Onset of DiabetEs in aSsociacion with pancreatic cancer (NODES trial): Protocol of a 7 8 Prospective, Multicentre Observational trial 9 10 11 12 13 Dóra Illés1, Emese Ivány1, Gábor Holzinger1, Klára Kosár1, Hajnalka Volosinovszki1, M. Gordian Adam2, 14 15 Beate Kamlage2, Gábor Zsóri1, Máté Tajti1, Márk Svébis3, Viktor Horváth 3, Ilona Oláh4, Katalin Márta5, 16 5 5 6 5,6 1 17 Judit Antal , Noémi Zádori , Andrea Szentesi , Péter Hegyi , László Czakó 18 For peer review only 19 20 21 22 23 24 25 26 27 1First Department of Medicine University of Szeged, Szeged, HU 28 2 29 Metanomics Health GmbH, Tegeler Weg 33, 10589 Berlin, Germany 30 3 First Department of Medicine University of Semmelweis, Budapest, HU 31 32 4Ilona Tóth Outpatient Clinic, Diabetes Care, Budapest, HU 33 34 5Insitute for Translational Medicine, Medical School, University of Pécs Medical School, Pécs, HU 35 6 36 Insitute for Translational Medicine, University of Szeged Medical School, Szeged, HU 37 http://bmjopen.bmj.com/ 38 39 Key words: new-onset diabetes mellitus, pancreatic cancer, biomarker, screening 40 41 42 43 Correspondence to: 44 László Czakó, MD, PhD, DSc 45 on September 24, 2021 by guest. Protected copyright. 46 First Department of Medicine, 47 48 University of Szeged, 49 Szeged, P.O.Box: 427, H-6701, Hungary 50 51 E-mail: [email protected] 52 53 Telephone: +36-62-545187, Fax: +36-62-545185 54 55 56 Word count: 3909 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 4 of 18 1 2 3 Strengths and limitations of this study: BMJ Open: first published as 10.1136/bmjopen-2020-037267 on 19 November 2020. Downloaded from 4 5 6 Strength 1: As patients are included prospectively, the study will yield a cohort to examine the metabolic 7 changes that coincide with the occurrence of pancreatic cancer at a very early stage before it is diagnosed. 8 9 Strength 2: The criteria for the diagnoses of diabetes and pancreatic cancer will be uniformly applied 10 11 throughout the study period, moreover the diagnosis of pancreatic cancer will be confirmed with a high 12 13 level of certainty in all subjects. 14 Strength 3: Taking part in the screening is connected to a very low burden, as the blood collection is only 15 16 minimally invasive. 17 18 Strength 4: All patients willFor be monitored peer closely review and frequently, only which will increase the survival of all 19 20 participants, especially the high-risk patients. 21 Limitation 1: It might be really difficult to include the required number of patients, consideing that PaC is 22 23 a rare disease, and the elderly population has more comorbidities which not even make our observation 24 25 more difficult, but also leads to a higher follow-up loss during the 36 months. 26 27 28 INTRODUCTION 29 30 31 32 Pancreatic cancer (PaC) is a rare disease with a lifetime prevalence of 1.39%, but its prevalence is 33 continuously increasing (1-3). The prognosis is extremely poor: it has the lowest five-year survival of all 34 35 cancers, only 6% (4), and this rate has not significantly changed in the last 40 years (5). PaC is projected to 36 be the third leading cause of cancer-related death by 2030 (6).
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