Nationwide comprehensive gastro-intestinal cancer cohorts: the 3P initiative.

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Nationwide comprehensive gastro-intestinal cancer cohorts: the 3P initiative.

Acta Oncol. 2017 Jul 19;:1-8

Authors: Coebergh van den Braak RRJ, van Rijssen LB, van Kleef JJ, Vink GR, Berbee M, van Berge Henegouwen MI, Bloemendal HJ, Bruno MJ, Burgmans MC, Busch ORC, Coene PPLO, Coupé VMH, Dekker JWT, van Eijck CHJ, Elferink MAG, Erdkamp FLG, van Grevenstein WMU, de Groot JWB, van Grieken NCT, de Hingh IHJT, Hulshof MCCM, Ijzermans JNM, Kwakkenbos L, Lemmens VEPP, Los M, Meijer GA, Molenaar IQ, Nieuwenhuijzen GAP, de Noo ME, van de Poll-Franse LV, Punt CJA, Rietbroek RC, Roeloffzen WWH, Rozema T, Ruurda JP, van Sandick JW, Schiphorst AHW, Schipper H, Siersema PD, Slingerland M, Sommeijer DW, Spaander MCW, Sprangers MAG, Stockmann HBAC, Strijker M, van Tienhoven G, Timmermans LM, Tjin-A-Ton MLR, van der Velden AMT, Verhaar MJ, Verkooijen HM, Vles WJ, de Vos-Geelen JMPGM, Wilmink JW, Zimmerman DDE, van Oijen MGH, Koopman M, Besselink MGH, van Laarhoven HWM, Dutch Pancreatic Cancer Group, Dutch Upper GI Cancer Group and PLCRC working group.

Abstract
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.

PMID: 28723307 [PubMed - as supplied by publisher]

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