1. Nationwide comprehensive gastro-intestinal cancer cohorts
- Author
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Braak, R.R.J.C. van den, Rijssen, L.B. van, Kleef, J.J. van, Vink, G.R., Berbee, M., Henegouwen, M.I.V., Bloemendal, H.J., Bruno, M.J., Burgmans, M.C., Busch, O.R.C., Coene, P.P.L.O., Coupe, V.M.H., Dekker, J.W.T., Eijck, C.H.J. van, Elferink, M.A.G., Erdkamp, F.L.G., Grevenstein, W.M.U. van, Groot, J.W.B. de, Grieken, N.C.T. van, Hingh, I.H.J.T. de, Hulshof, M.C.C.M., Ijzermans, J.N.M., Kwakkenbos, L., Lemmens, V.E.P.P., M. los, Meijer, G.A., Molenaar, I.Q., Nieuwenhuijzen, G.A.P., Noo, M.E. de, Poll-Franse, L.V. van de, Punt, C.J.A., Rietbroek, R.C., Roeloffzen, W.W.H., Rozema, T., Ruurda, J.P., Sandick, J.W. van, Schiphorst, A.H.W., Schipper, H., Siersema, P.D., Slingerland, M., Sommeijer, D.W., Spaander, M.C.W., Sprangers, M.A.G., Stockmann, H.B.A.C., Strijker, M., Tienhoven, G. van, Timmermans, L.M., Tjin-a-Ton, M.L.R., Velden, A.M.T. van der, Verhaar, M.J., Verkooijen, H.M., Vles, W.J., Vos-Geelen, J.M.P.G.M. de, Wilmink, J.W., Zimmerman, D.D.E., Oijen, M.G.H. van, Koopman, M., Besselink, M.G.H., Laarhoven, H.W.M. van, Dutch Pancreatic Canc Grp, Dutch Upper GI Canc Grp, PLCRC Working Grp, RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, Radiotherapie, Promovendi ODB, MUMC+: MA Radiotherapie OC (9), Interne Geneeskunde, MUMC+: MA Medische Oncologie (9), CCA - Cancer Treatment and quality of life, APH - Methodology, Epidemiology and Data Science, AGEM - Re-generation and cancer of the digestive system, Pathology, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, CCA - Cancer Treatment and Quality of Life, Surgery, Graduate School, Radiotherapy, Oncology, APH - Aging & Later Life, APH - Mental Health, Medical Psychology, APH - Quality of Care, Gastroenterology & Hepatology, Public Health, Erasmus MC other, and Medical and Clinical Psychology
- Subjects
0301 basic medicine ,medicine.medical_specialty ,INFRASTRUCTURE ,law.invention ,COLORECTAL-CANCER ,Cohort Studies ,Experimental Psychopathology and Treatment ,03 medical and health sciences ,Tumours of the digestive tract Radboud Institute for Health Sciences [Radboudumc 14] ,Cancer development and immune defence Radboud Institute for Health Sciences [Radboudumc 2] ,0302 clinical medicine ,All institutes and research themes of the Radboud University Medical Center ,Randomized controlled trial ,SDG 3 - Good Health and Well-being ,DESIGN ,law ,Informed consent ,MOLECULAR SUBTYPES ,medicine ,Humans ,QUALITY ,Radiology, Nuclear Medicine and imaging ,Registries ,Biological Specimen Banks ,Gastrointestinal Neoplasms ,Randomized Controlled Trials as Topic ,ESOPHAGEAL ,INFORMED-CONSENT ,business.industry ,Clinical study design ,Cancer ,Hematology ,General Medicine ,medicine.disease ,Surgery ,Cancer registry ,Clinical trial ,Observational Studies as Topic ,030104 developmental biology ,Oncology ,Research Design ,030220 oncology & carcinogenesis ,Cohort ,Emergency medicine ,business ,CLINICAL-TRIALS ,Cohort study - Abstract
Contains fulltext : 190038.pdf (Publisher’s version ) (Open Access) Background: The increasing sub-classification of cancer patients due to more detailed molecular classification of tumors, and limitations of current trial designs, require innovative research designs. We present the design, governance and current standing of three comprehensive nationwide cohorts including pancreatic, esophageal/gastric, and colorectal cancer patients (NCT02070146). Multidisciplinary collection of clinical data, tumor tissue, blood samples, and patient-reported outcome (PRO) measures with a nationwide coverage, provides the infrastructure for future and novel trial designs and facilitates research to improve outcomes of gastrointestinal cancer patients.Material and methods: All patients aged ≥18 years with pancreatic, esophageal/gastric or colorectal cancer are eligible. Patients provide informed consent for: (1) reuse of clinical data; (2) biobanking of primary tumor tissue; (3) collection of blood samples; (4) to be informed about relevant newly identified genomic aberrations; (5) collection of longitudinal PROs; and (6) to receive information on new interventional studies and possible participation in cohort multiple randomized controlled trials (cmRCT) in the future.Results: In 2015, clinical data of 21,758 newly diagnosed patients were collected in the Netherlands Cancer Registry. Additional clinical data on the surgical procedures were registered in surgical audits for 13,845 patients. Within the first two years, tumor tissue and blood samples were obtained from 1507 patients; during this period, 1180 patients were included in the PRO registry. Response rate for PROs was 90%. The consent rate to receive information on new interventional studies and possible participation in cmRCTs in the future was >85%. The number of hospitals participating in the cohorts is steadily increasing.Conclusion: A comprehensive nationwide multidisciplinary gastrointestinal cancer cohort is feasible and surpasses the limitations of classical study designs. With this initiative, novel and innovative studies can be performed in an efficient, safe, and comprehensive setting. 8 p.
- Published
- 2018
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