Nationwide comprehensive gastro-intestinal cancer cohorts

The 3P initiative

R. R. J. Coebergh Van Den Braak, L. B. Van Rijssen, J. J. Van Kleef, G. R. Vink, M. Berbee, M. I. Van Berge Henegouwen, H. J. Bloemendal, M. J. Bruno, M. C. Burgmans, O. R. C. Busch, P. P. L. O. Coene, V. M. H. Coupé, J. W. T. Dekker, C. H. J. Van Eijck, M. A. G. Elferink, F. L. G. Erdkamp, W. M. U. Van Grevenstein, J. W. B. De Groot, N. C. T. Van Grieken, I. H. J. T. De Hingh & 39 others M. C. C. M. Hulshof, J. N. M. Ijzermans, L. Kwakkenbos, V. E. P. P. Lemmens, M. Los, G. A. Meijer, I. Q. Molenaar, G. A. P. Nieuwenhuijzen, M. E. De Noo, L.V. van de Poll-Franse, C. J. A. Punt, R. C. Rietbroek, W. W. H. Roeloffzen, T. Rozema, J. P. Ruurda, J. W. Van Sandick, A. H. W. Schiphorst, H. Schipper, P. D. Siersema, M. Slingerland, D. W. Sommeijer, M. C. W. Spaander, M. A. G. Sprangers, H. B. A. C. Stockmann, M. Strijker, G. Van Tienhoven, L. M. Timmermans, M. L. R. Tjin-a-ton, A. M. T. Van Der Velden, M. J. Verhaar, H. M. Verkooijen, W. J. Vles, J. M. P. G. M. De Vos-geelen, J. W. Wilmink, D. D. E. Zimmerman, M. G. H. Van Oijen, M. Koopman, M. G. H. Besselink, H. W. M. Van Laarhoven

Research output: Contribution to journalArticleScientificpeer-review

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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.

Original languageEnglish
Pages (from-to)195-202
JournalActa Oncologica
Volume57
Issue number2
DOIs
Publication statusPublished - 2018

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Intestinal Neoplasms
Neoplasms
Gastrointestinal Neoplasms
Esophageal Neoplasms
Informed Consent
Netherlands

Keywords

  • CLINICAL-TRIALS
  • COLORECTAL-CANCER
  • DESIGN
  • ESOPHAGEAL
  • INFORMED-CONSENT
  • INFRASTRUCTURE
  • MOLECULAR SUBTYPES
  • QUALITY

Cite this

Coebergh Van Den Braak, R. R. J., Van Rijssen, L. B., Van Kleef, J. J., Vink, G. R., Berbee, M., Van Berge Henegouwen, M. I., ... Van Laarhoven, H. W. M. (2018). Nationwide comprehensive gastro-intestinal cancer cohorts: The 3P initiative. Acta Oncologica, 57(2), 195-202. https://doi.org/10.1080/0284186X.2017.1346381
Coebergh Van Den Braak, R. R. J. ; Van Rijssen, L. B. ; Van Kleef, J. J. ; Vink, G. R. ; Berbee, M. ; Van Berge Henegouwen, M. I. ; Bloemendal, H. J. ; Bruno, M. J. ; Burgmans, M. C. ; Busch, O. R. C. ; Coene, P. P. L. O. ; Coupé, V. M. H. ; Dekker, J. W. T. ; Van Eijck, C. H. J. ; Elferink, M. A. G. ; Erdkamp, F. L. G. ; Van Grevenstein, W. M. U. ; De Groot, J. W. B. ; Van Grieken, N. C. T. ; De Hingh, I. H. J. T. ; Hulshof, M. C. C. M. ; Ijzermans, J. N. M. ; Kwakkenbos, L. ; Lemmens, V. E. P. P. ; Los, M. ; Meijer, G. A. ; Molenaar, I. Q. ; Nieuwenhuijzen, G. A. P. ; De Noo, M. E. ; van de Poll-Franse, L.V. ; Punt, C. J. A. ; Rietbroek, R. C. ; Roeloffzen, W. W. H. ; Rozema, T. ; Ruurda, J. P. ; Van Sandick, J. W. ; 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. ; Van Tienhoven, G. ; Timmermans, L. M. ; Tjin-a-ton, M. L. R. ; Van Der Velden, A. M. T. ; Verhaar, M. J. ; Verkooijen, H. M. ; Vles, W. J. ; De Vos-geelen, J. M. P. G. M. ; Wilmink, J. W. ; Zimmerman, D. D. E. ; Van Oijen, M. G. H. ; Koopman, M. ; Besselink, M. G. H. ; Van Laarhoven, H. W. M. / Nationwide comprehensive gastro-intestinal cancer cohorts : The 3P initiative. In: Acta Oncologica. 2018 ; Vol. 57, No. 2. pp. 195-202.
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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.",
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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 2018, 'Nationwide comprehensive gastro-intestinal cancer cohorts: The 3P initiative', Acta Oncologica, vol. 57, no. 2, pp. 195-202. https://doi.org/10.1080/0284186X.2017.1346381

Nationwide comprehensive gastro-intestinal cancer cohorts : The 3P initiative. / Coebergh Van Den Braak, R. R. J.; Van Rijssen, L. B.; Van Kleef, J. J.; Vink, G. R.; Berbee, M.; Van Berge Henegouwen, M. I.; Bloemendal, H. J.; Bruno, M. J.; Burgmans, M. C.; Busch, O. R. C.; Coene, P. P. L. O.; Coupé, V. M. H.; Dekker, J. W. T.; Van Eijck, C. H. J.; Elferink, M. A. G.; Erdkamp, F. L. G.; Van Grevenstein, W. M. U.; De Groot, J. W. B.; Van Grieken, N. C. T.; De Hingh, I. H. J. T.; Hulshof, M. C. C. M.; Ijzermans, J. N. M.; Kwakkenbos, L.; Lemmens, V. E. P. P.; Los, M.; Meijer, G. A.; Molenaar, I. Q.; Nieuwenhuijzen, G. A. P.; De Noo, M. E.; van de Poll-Franse, L.V.; Punt, C. J. A.; Rietbroek, R. C.; Roeloffzen, W. W. H.; Rozema, T.; Ruurda, J. P.; Van Sandick, J. W.; 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.; Van Tienhoven, G.; Timmermans, L. M.; Tjin-a-ton, M. L. R.; Van Der Velden, A. M. T.; Verhaar, M. J.; Verkooijen, H. M.; Vles, W. J.; De Vos-geelen, J. M. P. G. M.; Wilmink, J. W.; Zimmerman, D. D. E.; Van Oijen, M. G. H.; Koopman, M.; Besselink, M. G. H.; Van Laarhoven, H. W. M.

In: Acta Oncologica, Vol. 57, No. 2, 2018, p. 195-202.

Research output: Contribution to journalArticleScientificpeer-review

TY - JOUR

T1 - Nationwide comprehensive gastro-intestinal cancer cohorts

T2 - The 3P initiative

AU - Coebergh Van Den Braak, R. R. J.

AU - Van Rijssen, L. B.

AU - Van Kleef, J. J.

AU - Vink, G. R.

AU - Berbee, M.

AU - Van Berge Henegouwen, M. I.

AU - Bloemendal, H. J.

AU - Bruno, M. J.

AU - Burgmans, M. C.

AU - Busch, O. R. C.

AU - Coene, P. P. L. O.

AU - Coupé, 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 - Verkooijen, H. M.

AU - Vles, W. J.

AU - De Vos-geelen, J. M. P. G. M.

AU - Wilmink, J. W.

AU - Zimmerman, D. D. E.

AU - Van Oijen, M. G. H.

AU - Koopman, M.

AU - Besselink, M. G. H.

AU - Van Laarhoven, H. W. M.

PY - 2018

Y1 - 2018

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 - COLORECTAL-CANCER

KW - DESIGN

KW - ESOPHAGEAL

KW - INFORMED-CONSENT

KW - INFRASTRUCTURE

KW - MOLECULAR SUBTYPES

KW - QUALITY

U2 - 10.1080/0284186X.2017.1346381

DO - 10.1080/0284186X.2017.1346381

M3 - Article

VL - 57

SP - 195

EP - 202

JO - Acta Oncologica

JF - Acta Oncologica

SN - 0284-186X

IS - 2

ER -

Coebergh Van Den Braak RRJ, Van Rijssen LB, Van Kleef JJ, Vink GR, Berbee M, Van Berge Henegouwen MI et al. Nationwide comprehensive gastro-intestinal cancer cohorts: The 3P initiative. Acta Oncologica. 2018;57(2):195-202. https://doi.org/10.1080/0284186X.2017.1346381