TY - JOUR
T1 - Nationwide comprehensive gastro-intestinal cancer cohorts
T2 - the 3P initiative
AU - van den Braak, R. R. J. Coebergh
AU - van Rijssen, L. B.
AU - van Kleef, J. J.
AU - Vink, G. R.
AU - Berbee, M.
AU - Henegouwen, M. I. van Berge
AU - Bloemendal, H. J.
AU - Bruno, M. J.
AU - Burgmans, M. C.
AU - Busch, O. R. C.
AU - Coene, P. P. L. O.
AU - Coupe, V. M. H.
AU - Dekker, J. W. T.
AU - van Eijck, C. H. J.
AU - Elferink, M. A. G.
AU - Erdkamp, F. L. G.
AU - van Grevenstein, W. M. U.
AU - de Groot, J. W. B.
AU - van Grieken, N. C. T.
AU - de Hingh, I. H. J. T.
AU - Hulshof, M. C. C. M.
AU - Ijzermans, J. N. M.
AU - Kwakkenbos, L.
AU - Lemmens, V. E. P. P.
AU - Los, M.
AU - Meijer, G. A.
AU - Molenaar, I. Q.
AU - Nieuwenhuijzen, G. A. P.
AU - de Noo, M. E.
AU - van de Poll-Franse, L. V.
AU - Punt, C. J. A.
AU - Rietbroek, R. C.
AU - Roeloffzen, W. W. H.
AU - Rozema, T.
AU - Ruurda, J. P.
AU - van Sandick, J. W.
AU - Schiphorst, A. H. W.
AU - Schipper, H.
AU - Siersema, P. D.
AU - Slingerland, M.
AU - Sommeijer, D. W.
AU - Spaander, M. C. W.
AU - Sprangers, M. A. G.
AU - Stockmann, H. B. A. C.
AU - Strijker, M.
AU - van Tienhoven, G.
AU - Timmermans, L. M.
AU - Tjin-a-Ton, M. L. R.
AU - van der Velden, A. M. T.
AU - Verhaar, M. J.
AU - de Vos-Geelen, J.M.P.G.M.
AU - Verkooijen, Helena M.
AU - Vles, W.J.
AU - Wilmink, J.W.
AU - Zimmerman, D. D.
AU - van Ooijen, M.G.H.
AU - Koopman, M.
AU - Besselink, Marc G.
AU - van Laarhoven, H. W. M.
AU - Dutch Pancreatic Canc Grp; Dutch Upper GI Canc Grp; PLCRC Working Grp
PY - 2018/1/1
Y1 - 2018/1/1
N2 - 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.
AB - 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.
KW - CLINICAL-TRIALS
KW - MOLECULAR SUBTYPES
KW - COLORECTAL-CANCER
KW - INFORMED-CONSENT
KW - QUALITY
KW - INFRASTRUCTURE
KW - ESOPHAGEAL
KW - DESIGN
U2 - 10.1080/0284186X.2017.1346381
DO - 10.1080/0284186X.2017.1346381
M3 - Article
C2 - 28723307
SN - 0284-186X
VL - 57
SP - 195
EP - 202
JO - Acta Oncologica
JF - Acta Oncologica
IS - 2
ER -