New Onset of DiabetEs in aSsociation with pancreatic ductal adenocarcinoma (NODES Trial): protocol of a prospective, multicentre observational trial
| Autor: | Katalin Márta, M Gordian Adam, Dóra Illés, Bálint L Czakó, László Czakó, Péter Hegyi, Beate Kamlage, V Horvath, Máté Tajti, Márk M. Svébis, Ilona Oláh, Gábor Holzinger, Gábor Zsóri, Andrea Szentesi, Klára Kosár, Noémi Zádori, Emese Ivány, Szilárd Váncsa |
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| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
Pancreatic disease protocols & guidelines medicine.medical_treatment Population preventive medicine Internal medicine Diabetes mellitus medicine Diabetes Mellitus Humans Prospective Studies education Early Detection of Cancer education.field_of_study Hungary business.industry Incidence (epidemiology) Mortality rate general diabetes General Medicine Middle Aged medicine.disease Pancreatic Neoplasms Diabetes and Endocrinology Pancreatectomy Pancreatitis Medicine business Cohort study Carcinoma Pancreatic Ductal pancreatic disease |
| Zdroj: | BMJ Open BMJ Open, Vol 10, Iss 11 (2020) |
| ISSN: | 2044-6055 |
| Popis: | IntroductionPancreatic 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 analysisThis 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 disseminationThe 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 numberClinicalTrials.govNCT04164602 |
| Databáze: | OpenAIRE |
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