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1. The Prospective Dutch Colorectal Cancer (PLCRC) cohort: real-world data facilitating research and clinical care

Author

Derksen, J.W.G. (Jeroen W. G.), Vink, G.R. (Geraldine R.), Elferink, M.A.G. (Marloes), Roodhart, J.M. (Jeanine), Verkooijen, H.M. (Helena M.), Grevenstein, H.M.U. (Helma) van, Siersema, P.D. (Peter), May, A.M. (Anne M.), Koopman, M. (Miriam), Beets, G.L. (Geerard), Belt, E.J.T. (Eric), Berbée, M. (Maaike), Beverdam, F.H. (Frederique H.), Blankenburgh, R. (Ruud), Coene, P-P. (Peter Paul), van Cruijsen, H. (Hester), Dekker, J.W.T. (Jan Willem), van Dodewaard-de Jong, J.M. (Joyce M.), Erdkamp, F.L.G. (Frans ), Groot, J.W.B. (Jan Willem) de, Haringhuizen, A.W. (Annebeth W.), Helgason, H.H. (Helgi H.), Hendriks, M.P. (Mathijs P.), Hingh, I.H.J.T. (Ignace) de, Hoekstra, R. (Ronald), IJzermans, J.N.M. (Jan), Jansen, J. (Jan), Kloppenberg, F.W.H. (Frank W. H.), Lent, A.U. (Anja) van, Los, M., Meijerink, M.R. (Martijn R.), Mekenkamp, L.J.M. (Leonie J. M.), Nieboer, P. (Peter), Peeters, K.C.M.J. (Koen C.M.J.), Peters, N.A.J.B. (Natascha A. J. B.), Polee, M.B. (Marco), Pruijt, J.F.M., Punt, C.J.A. (Cornelis), van Ufford-Mannesse, P.Q. (Patricia Quarles), Rietbroek, R.C. (Ron), Schiphorst, A.H.W. (Anandi H. W.), van der Velden, A.S. (Arjan Schouten), Schrauwen, R.W.M. (Ruud W. M.), Sie, M.P.S. (Mark P. S.), Simkens, L.H.J. (L. H J), Sommeijer, D.W. (Dirkje W.), Sonneveld, D.J.A., Spierings, L.E.A. (Leontine E. A.), Stockmann, H.B.A.C. (Hein), Talsma, A.K. (Aaldert), Terheggen, F. (Frederiek), Tije, A.J. (Albert Jan) ten, Tjin-A-Ton, M.L.R. (Manuel L. R.), Valkenburg-van Iersel, L.B.J. (Liselot B. J.), Veenstra, R.P., Velden, A.M.T. van der, Vermaas, M. (Maarten), Vles, W., Vogelaar, J.F.J. (Jeroen F. J.), van Voorthuizen, T. (Theo), Vos, A.I. (Aad) de, Wegdam, J.A. (J.), Wilt, J.H.W. (Johannes) de, Zimmerman, D.D.E. (David), Derksen, J.W.G. (Jeroen W. G.), Vink, G.R. (Geraldine R.), Elferink, M.A.G. (Marloes), Roodhart, J.M. (Jeanine), Verkooijen, H.M. (Helena M.), Grevenstein, H.M.U. (Helma) van, Siersema, P.D. (Peter), May, A.M. (Anne M.), Koopman, M. (Miriam), Beets, G.L. (Geerard), Belt, E.J.T. (Eric), Berbée, M. (Maaike), Beverdam, F.H. (Frederique H.), Blankenburgh, R. (Ruud), Coene, P-P. (Peter Paul), van Cruijsen, H. (Hester), Dekker, J.W.T. (Jan Willem), van Dodewaard-de Jong, J.M. (Joyce M.), Erdkamp, F.L.G. (Frans ), Groot, J.W.B. (Jan Willem) de, Haringhuizen, A.W. (Annebeth W.), Helgason, H.H. (Helgi H.), Hendriks, M.P. (Mathijs P.), Hingh, I.H.J.T. (Ignace) de, Hoekstra, R. (Ronald), IJzermans, J.N.M. (Jan), Jansen, J. (Jan), Kloppenberg, F.W.H. (Frank W. H.), Lent, A.U. (Anja) van, Los, M., Meijerink, M.R. (Martijn R.), Mekenkamp, L.J.M. (Leonie J. M.), Nieboer, P. (Peter), Peeters, K.C.M.J. (Koen C.M.J.), Peters, N.A.J.B. (Natascha A. J. B.), Polee, M.B. (Marco), Pruijt, J.F.M., Punt, C.J.A. (Cornelis), van Ufford-Mannesse, P.Q. (Patricia Quarles), Rietbroek, R.C. (Ron), Schiphorst, A.H.W. (Anandi H. W.), van der Velden, A.S. (Arjan Schouten), Schrauwen, R.W.M. (Ruud W. M.), Sie, M.P.S. (Mark P. S.), Simkens, L.H.J. (L. H J), Sommeijer, D.W. (Dirkje W.), Sonneveld, D.J.A., Spierings, L.E.A. (Leontine E. A.), Stockmann, H.B.A.C. (Hein), Talsma, A.K. (Aaldert), Terheggen, F. (Frederiek), Tije, A.J. (Albert Jan) ten, Tjin-A-Ton, M.L.R. (Manuel L. R.), Valkenburg-van Iersel, L.B.J. (Liselot B. J.), Veenstra, R.P., Velden, A.M.T. van der, Vermaas, M. (Maarten), Vles, W., Vogelaar, J.F.J. (Jeroen F. J.), van Voorthuizen, T. (Theo), Vos, A.I. (Aad) de, Wegdam, J.A. (J.), Wilt, J.H.W. (Johannes) de, and Zimmerman, D.D.E. (David)

Abstract

Real-world data (RWD) sources are important to advance clinical oncology research and evaluate treatments in daily practice. Since 2013, the Prospective Dutch Colorectal Cancer (PLCRC) cohort, linked to the Netherlands Cancer Registry, serves as an infrastructure for scientific research collecting additional patient-reported outcomes (PRO) and biospecimens. Here we report on cohort developments and investigate to what extent PLCRC reflects the “real-world”. Clinical and demographic characteristics of PLCRC participants were compared with the general Dutch CRC population (n = 74,692, Dutch-ref). To study representativeness, standardized differences between PLCRC and Dutch-ref were calculated, and logistic regression models were evaluated on their ability to distinguish cohort participants from the Dutch-ref (AU-ROC 0.5 = preferred, implying participation independent of patient characteristics). Stratified analyses by stage and time-period (2013–2016 and 2017–Aug 2019) were performed to study the evolution towards RWD. In August 2019, 5744 patients were enrolled. Enrollment increased steeply, from 129 participants (1 hospital) in 2013 to 2136 (50 of 75 Dutch hospitals) in 2018. Low AU-ROC (0.65, 95% CI: 0.64–0.65) indicates limited ability to distinguish cohort participants from the Dutch-ref. Characteristics that remained imbalanced in the period 2017–Aug’19 compared with the Dutch-ref were age (65.0 years in PLCRC, 69.3 in the Dutch-ref) and tumor stage (40% stage-III in PLCRC, 30% in the Dutch-ref). PLCRC approaches to represent the Dutch CRC population and will ultimately meet the current demand for high-quality RWD. Efforts are ongoing to improve multidisciplinary recruitment which will further enhance PLCRC’s representativeness and its contribution to a learning healthcare system.

Published
2021
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2. Nationwide comprehensive gastro-intestinal cancer cohorts

Author

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

Author

Coebergh van den Braak, R.R.J. (Robert), van Rijssen, L.B. (Lennart B.), van Kleef, J.J. (J. J.), Vink, G.R. (G. R.), Berbee, M. (M.), van Berge Henegouwen, M.I., Bloemendal, H.J. (Haiko), Bruno, M.J. (Marco), Burgmans, M.C. (M. C.), Busch, O.R.C. (Olivier), Coene, P-P. (Peter Paul), Coupé, V.M.H. (Veerle), Dekker, J.W.T. (Jan Willem), Eijck, C.H.J. (Casper) van, Elferink, M.A.G. (Marloes), Erdkamp, F.L.G. (Frans ), Grevenstein, H.M.U. (Helma) van, Groot, J.W.B. (Jan Willem) de, Grieken, N.C.T. (Nicole), Hingh, I.H.J.T. (Ignace) de, Hulshof, M.C.C.M. (Maarten), IJzermans, J.N.M. (Jan), Kwakkenbos, L. (L.), Lemmens, V.E.P.P. (Valery), Los, M., Meijer, C.J.L.M. (Chris), Molenaar, I.Q. (I. Quintus), Nieuwenhuijzen, G.A.P. (Gerard), de Noo, M.E. (M. E.), Poll-Franse, L.V. (Lonneke) van de, Punt, C.J.A. (Cornelis), Rietbroek, R.C. (Ron), Roeloffzen, W.W.H. (W. W.H.), Rozema, T. (Tom), Ruurda, J.P. (Jelle), Sandick, J.W. (J.) van, Schiphorst, A.H.W. (A. H.W.), Schipper, H. (H.), Siersema, P.D. (Peter), Slingerland, M. (Marije), Sommeijer, D.W. (D. W.), Spaander, M.C.W. (Manon), Sprangers, M.A.G. (Mirjam), Stockmann, H.B.A.C. (Hein), Strijker, M. (M.), Tienhoven, G. (Geertjan) van, Timmermans, L.M. (L. M.), Tjin-a-Ton, M.L.R. (M. L.R.), Velden, A.M.T. van der, Verhaar, M.J. (M. J.), Verkooijen, H.M. (Helena M.), Vles, W., de Vos-Geelen, J. (Judith), Wilmink, J.W. (Johanna), Zimmerman, D.D.E. (David), Oijen, M.G.H. (Martijn) van, Koopman, M. (Miriam), Besselink, M.G. (Marc), Laarhoven, H.W.M. (Hanneke) van, Coebergh van den Braak, R.R.J. (Robert), van Rijssen, L.B. (Lennart B.), van Kleef, J.J. (J. J.), Vink, G.R. (G. R.), Berbee, M. (M.), van Berge Henegouwen, M.I., Bloemendal, H.J. (Haiko), Bruno, M.J. (Marco), Burgmans, M.C. (M. C.), Busch, O.R.C. (Olivier), Coene, P-P. (Peter Paul), Coupé, V.M.H. (Veerle), Dekker, J.W.T. (Jan Willem), Eijck, C.H.J. (Casper) van, Elferink, M.A.G. (Marloes), Erdkamp, F.L.G. (Frans ), Grevenstein, H.M.U. (Helma) van, Groot, J.W.B. (Jan Willem) de, Grieken, N.C.T. (Nicole), Hingh, I.H.J.T. (Ignace) de, Hulshof, M.C.C.M. (Maarten), IJzermans, J.N.M. (Jan), Kwakkenbos, L. (L.), Lemmens, V.E.P.P. (Valery), Los, M., Meijer, C.J.L.M. (Chris), Molenaar, I.Q. (I. Quintus), Nieuwenhuijzen, G.A.P. (Gerard), de Noo, M.E. (M. E.), Poll-Franse, L.V. (Lonneke) van de, Punt, C.J.A. (Cornelis), Rietbroek, R.C. (Ron), Roeloffzen, W.W.H. (W. W.H.), Rozema, T. (Tom), Ruurda, J.P. (Jelle), Sandick, J.W. (J.) van, Schiphorst, A.H.W. (A. H.W.), Schipper, H. (H.), Siersema, P.D. (Peter), Slingerland, M. (Marije), Sommeijer, D.W. (D. W.), Spaander, M.C.W. (Manon), Sprangers, M.A.G. (Mirjam), Stockmann, H.B.A.C. (Hein), Strijker, M. (M.), Tienhoven, G. (Geertjan) van, Timmermans, L.M. (L. M.), Tjin-a-Ton, M.L.R. (M. L.R.), Velden, A.M.T. van der, Verhaar, M.J. (M. J.), Verkooijen, H.M. (Helena M.), Vles, W., de Vos-Geelen, J. (Judith), Wilmink, J.W. (Johanna), Zimmerman, D.D.E. (David), Oijen, M.G.H. (Martijn) van, Koopman, M. (Miriam), Besselink, M.G. (Marc), and Laarhoven, H.W.M. (Hanneke) van

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 t

Published
2018
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5. Impact of sarcopenia on dose limiting toxicities in metastatic colorectal cancer patients (mCRC pts) receiving palliative systemic treatment

Author

Kurk, S., Peeters, P., Stellato, R., Dorresteijn, Bram, Jourdan, M., Creemers, G.J., Erdkamp, Frans, de Jongh, Felix E, Kint, P., Poppema, B., Radema, S.A, Simkens, L.H., Tanis, B., Tjin-A-Ton, M.L.R., Van der Velden, A., Punt, C. J A, Koopman, M., May, A., Kurk, S., Peeters, P., Stellato, R., Dorresteijn, Bram, Jourdan, M., Creemers, G.J., Erdkamp, Frans, de Jongh, Felix E, Kint, P., Poppema, B., Radema, S.A, Simkens, L.H., Tanis, B., Tjin-A-Ton, M.L.R., Van der Velden, A., Punt, C. J A, Koopman, M., and May, A.

Published
2017

6. Impact of sarcopenia on dose limiting toxicities in metastatic colorectal cancer patients (mCRC pts) receiving palliative systemic treatment

Author

MS Medische Oncologie, Cancer, Epi Kanker Team 1, JC onderzoeksprogramma Kanker, Biostatistiek Onderwijs, Other research (not in main researchprogram), JC onderzoeksprogramma Methodologie, Kurk, S., Peeters, P., Stellato, R., Dorresteijn, Bram, Jourdan, M., Creemers, G.J., Erdkamp, Frans, de Jongh, Felix E, Kint, P., Poppema, B., Radema, S.A, Simkens, L.H., Tanis, B., Tjin-A-Ton, M.L.R., Van der Velden, A., Punt, C. J A, Koopman, M., May, A., MS Medische Oncologie, Cancer, Epi Kanker Team 1, JC onderzoeksprogramma Kanker, Biostatistiek Onderwijs, Other research (not in main researchprogram), JC onderzoeksprogramma Methodologie, Kurk, S., Peeters, P., Stellato, R., Dorresteijn, Bram, Jourdan, M., Creemers, G.J., Erdkamp, Frans, de Jongh, Felix E, Kint, P., Poppema, B., Radema, S.A, Simkens, L.H., Tanis, B., Tjin-A-Ton, M.L.R., Van der Velden, A., Punt, C. J A, Koopman, M., and May, A.

Published
2017

7. Unexpected overdose with diltiazem: value of toxicological screening

Author

Kamphuisen, P.W., Karreman, M., Tjin-A-Ton, M.L.R., Bosker, H.A., and van Nieuwenhuizen, R.

Subjects
Case Report
Abstract

We describe a 59-year-old woman who was admitted in deep coma with bradycardia, hypotension and fixed pupils. The cause of her severe condition was unclear. Cerebral and myocardial infarction was excluded. Temporary transcutaneous pacing was not successful, nor was atropine or norepinephrine (noradrenaline), but the patient responded well to isoprenaline infusion. Since she was known to have a psychiatric history, toxicological screening was performed which showed a severe diltiazem overdose. Later we discovered that she took diltiazem for angina pectoris. The patient survived and was discharged without neurological or cardiological deficits after two days of treatment. This case report emphasises the importance of toxicological screening in unconscious patients with no apparent cause. We review the clinical features and treatment options of diltiazem overdose and discuss the value of toxicological screening.

Published
2001

8. 8116 POSTER Multidisciplinary management of toxicities EGFR-inhibitors

Author

Koldenhof, J.J., primary, Tjin-A-Ton, M.L.R., additional, van Montfrans, C., additional, van den Heuvel, I.J.G.M., additional, Klein Wolterink, H.M., additional, Kronemeijer, R.H., additional, Verkleij, S.M., additional, Tjia, P.F., additional, Witteveen, P.O., additional, and Teunissen, S.C.C.M., additional

Published
2007
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