Prospective Data Collection Initiative on Colorectal Cancer
NCT ID: NCT02070146
Last Updated: 2025-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50000 participants
OBSERVATIONAL
2013-05-31
2051-01-31
Brief Summary
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Although the results from prospective clinical trials will remain the backbone of evidence based medicine, this concerns a highly selected patient population since the large majority (85%-95%) of cancer patients do not participate in clinical trials for various reasons. It is unlikely that trial participation will significantly improve in the near future. This fact has the following implications: 1) It is highly desirable to validate the results from trials in the general patient population. However, this is complicated by the fact that the documentation of patients treated in general practice (i.e. outside the scope of clinical trials) is largely insufficient to provide comparable patient cohorts in terms of prognostic characteristics and treatment parameters. 2) There is an increased availability of novel technologies that provide molecular markers with potential prognostic and/or predictive value. To test the clinical value of these markers large numbers of patients are required which greatly exceeds the number of patients who consent to participate in prospective clinical trials. 3) as a result of rapid technical developments, a range of new minimally invasive treatment options are entering the market. These interventions have the potential to be of great benefit for patients in terms of improved local control, higher probability of complete tumor removal, less damage to surrounding tissue, faster recovery and less short and long term side effects. Still, the interventions will have to prove their effectiveness, safety and superiority (or non-inferiority) to standard cancer treatments on a patient level. A prospective observational cohort study has the great opportunity to fill this gap.
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Detailed Description
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* To start a prospective observational cohort study of CRC, small bowel and anal cancer patients from their primary diagnosis until death.
* After obtaining Informed Consent, to prospectively collect data on medical history, comorbidities, baseline clinical parameters, imaging results, pathology results, tumor characteristics, treatment, treatment outcomes, hospital stays, interventions and (S)AEs.
* After obtaining separate Informed Consent for collecting data on health related quality of life and work ability, to collect data on patient reported outcome measures.
* After obtaining separate Informed Consent, to collect blood, (tumor) tissue or other body material, obtained during routine practice, for observational studies or storage in the biobank.
* The cohort will serve as an infrastructure geared towards efficient, safe and comprehensive clinical evaluation of new interventions for patients with CRC according to the Trials within Cohorts (TwiCs) design.
Expected outcome
* More accurate data on the treatment and clinical and patient reported outcomes of CRC, small bowel and anal cancer in daily practice.
* A continuous infrastructure for a large variety of research purposes including:
A. Prognostic and predictive research. B. Molecular research and (epi)genetic research. C. Comparison of new interventions for patients with CRC, small bowel and anal cancer according to the Trials within Cohorts (TwiCs) design. D. Health care policies and cost-effectiveness studies.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Histological proof of colorectal, small bowel and anal cancer, or a strong suspicion after imaging.
* Informed consent for longitudinal observational data collection.
Exclusion Criteria
Participation of patients to the PLCRC project does not exclude participation in any other ongoing or future study.
18 Years
ALL
No
Sponsors
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Dutch Colorectal Cancer Group
OTHER
Responsible Party
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Principal Investigators
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Miriam Koopman, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
UMC Utrecht
Locations
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ZorgSaam
Terneuzen, , Netherlands
Haaglanden MC
The Hague, , Netherlands
HagaZiekenhuis
The Hague, , Netherlands
Ziekenhuis Rivierenland
Tiel, , Netherlands
Elisabeth-TweeSteden Ziekenhuis
Tilburg, , Netherlands
Diakonessenhuis
Utrecht, , Netherlands
UMC Utrecht
Utrecht, , Netherlands
VieCuri Medisch Centrum
Venlo, , Netherlands
St. Jans Gasthuis
Weert, , Netherlands
Zaans Medisch Centrum
Zaandam, , Netherlands
Isala
Zwolle, , Netherlands
Frisius MC Leeuwarden
Leeuwarden, , Netherlands
Alrijne
Leiden, , Netherlands
Ikazia Ziekenhuis
Rotterdam, , Netherlands
Maasstad Ziekenhuis
Rotterdam, , Netherlands
Zuyderland Medisch Centrum
Sittard, , Netherlands
Antonius Ziekenhuis
Sneek, , Netherlands
Leids Universitair Medisch Centrum
Leiden, , Netherlands
Maastricht UMC+
Maastricht, , Netherlands
MAASTRO
Maastricht, , Netherlands
St. Antonius ziekenhuis
Nieuwegein, , Netherlands
Canisius Wilhelmina Ziekenhuis
Nijmegen, , Netherlands
Radboud UMC
Nijmegen, , Netherlands
Bernhoven
Oss, , Netherlands
Laurentius Ziekenhuis
Roermond, , Netherlands
Bravis ziekenhuis
Roosendaal, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
Franciscus Gasthuis & Vlietland
Rotterdam, , Netherlands
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, , Netherlands
Noordwest Ziekenhuisgroep
Alkmaar, , Netherlands
Flevoziekenhuis
Almere Stad, , Netherlands
Meander Medisch Centrum
Amersfoort, , Netherlands
Ziekenhuis Amstelland
Amstelveen, , Netherlands
Antoni van Leeuwenhoek
Amsterdam, , Netherlands
OLVG
Amsterdam, , Netherlands
VUmc
Amsterdam, , Netherlands
Gelre Ziekenhuizen
Apeldoorn, , Netherlands
Rijnstate
Arnhem, , Netherlands
Wilhelmina Ziekenhuis Assen
Assen, , Netherlands
Maasziekenhuis Pantein
Beugen, , Netherlands
Rode Kruis Ziekenhuis
Beverwijk, , Netherlands
Amphia ziekenhuis
Breda, , Netherlands
IJsselland Ziekenhuis
Capelle aan den IJssel, , Netherlands
Reinier de Graaf
Delft, , Netherlands
Deventer Ziekenhuizen
Deventer, , Netherlands
Van Weel-Bethesda Ziekenhuis
Dirksland, , Netherlands
Slingeland Ziekenhuis
Doetinchem, , Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht, , Netherlands
Ziekenhuis Gelderse Vallei
Ede, , Netherlands
Catharina Ziekenhuis
Eindhoven, , Netherlands
Maxima Medisch Centrum
Eindhoven, , Netherlands
Medisch Spectrum Twente
Enschede, , Netherlands
Anna Ziekenhuis
Geldrop, , Netherlands
Admiraal De Ruyter Ziekenhuis
Goes, , Netherlands
Rivas Beaterix Ziekenhuis
Gorinchem, , Netherlands
Groene Hart Ziekenhuis
Gouda, , Netherlands
Martini Ziekenhuis
Groningen, , Netherlands
UMC Groningen
Groningen, , Netherlands
Spaarne Gasthuis
Haarlem, , Netherlands
Saxenburgh Groep
Hardenberg, , Netherlands
St.Jansdal
Harderwijk, , Netherlands
Frisius MC Heerenveen
Heerenveen, , Netherlands
Elkerliek Ziekenhuis
Helmond, , Netherlands
Ziekenhuisgroep Twente
Hengelo, , Netherlands
Tergooi
Hilversum, , Netherlands
Treant Zorggroep
Hoogeveen, , Netherlands
Dijklander Ziekenhuis
Hoorn, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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J.F.M. Pruijt
Role: primary
M.P. Hendriks
Role: primary
D. Sommeijer
Role: primary
J.M. van Dodewaard
Role: primary
T. Kuiper
Role: primary
N.F.M. Kok
Role: primary
A.U.G van Lent
Role: primary
M.R. Meijerink
Role: primary
P. van Duijvendijk
Role: primary
T. van Voorthuizen
Role: primary
P. Nieboer
Role: primary
A. Goosens
Role: primary
J. Schreinemakers
Role: primary
M. Vermaas
Role: primary
J.W.T. Dekker
Role: primary
K. Talsma
Role: primary
A.I. de Vos
Role: primary
R.A.W. van de Wetering
Role: primary
E.J.Th. Belt
Role: primary
A.W. Haringhuizen
Role: primary
I.H.J.T. de Hingh
Role: primary
L. Simkens
Role: primary
L. Mekenkamp
Role: primary
J. Jansen
Role: primary
M.A. Davidis
Role: primary
M. Cloos-van Balen
Role: primary
R.P. Veenstra
Role: primary
G. Hospers
Role: primary
H.B.A.C. Stockmann
Role: primary
R. Blankenburgh
Role: primary
A.P. Schouten van der Velden
Role: primary
J. de Boer
Role: primary
J.A. Wegdam
Role: primary
R. Hoekstra
Role: primary
A. van der Velden
Role: primary
M. Tent
Role: primary
D.J.A. Sonneveld
Role: primary
M.B. Polée
Role: primary
L.E.A.M.M. Spierings
Role: primary
K.C.M. Peeters
Role: primary
L.B.J. Valkenburg
Role: primary
M. Berbée
Role: primary
M. Los
Role: primary
J.J.B. Janssen
Role: primary
J.H.W. de Wilt
Role: primary
R.W.M. Schrauwen
Role: primary
G.H.E.J. Vijgen
Role: primary
F. Terheggen
Role: primary
P.J. Tanis
Role: primary
M. Verseveld
Role: primary
W.J. Vles
Role: primary
P.P.L.O Coene
Role: primary
B. Scholtes
Role: primary
H. van Cruijsen
Role: primary
M.P.S. Sie
Role: primary
F.J.F. Jeurissen
Role: primary
D. Houtsma
Role: primary
M. Tjin-A-Ton
Role: primary
D.D.E Zimmerman
Role: primary
A. Schiphorst
Role: primary
Miriam Koopman
Role: primary
J. Konsten
Role: primary
N.A.J.B. Peters
Role: primary
G. Musters
Role: primary
J.W. de Groot
Role: primary
References
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Smit KC, Derksen JWG, Stellato RK, VAN Lanen AS, Wesselink E, Belt EJT, Balen MC, Coene PPLO, Dekker JWT, DE Groot JW, Haringhuizen AW, VAN Halteren HK, VAN Heek TT, Helgason HH, Hendriks MP, DE Hingh IHJT, Hoekstra R, Houtsma D, Janssen JJB, Kok N, Konsten JLM, Los M, Meijerink MR, Mekenkamp LJM, Peeters KCMJ, Polee MB, Rietbroek RC, Schiphorst AHW, Schrauwen RWM, Schreinemakers J, Sie MPS, Simkens L, Sonneveld EJA, Terheggen F, Iersel LV, Vles WJ, Wasowicz-Kemps DK, DE Wilt JHW, Kok DE, Winkels RM, Kampman E, VAN Duijnhoven FJB, Koopman M, May AM. Determinants of Physical Activity among Patients with Colorectal Cancer: From Diagnosis to 5 Years after Diagnosis. Med Sci Sports Exerc. 2024 Apr 1;56(4):623-634. doi: 10.1249/MSS.0000000000003351. Epub 2023 Nov 27.
Other Identifiers
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12-510
Identifier Type: -
Identifier Source: org_study_id
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