Prospective Data Collection Initiative on Colorectal Cancer (PLCRC)

Prospective Data Collection Initiative on Colorectal Cancer - a Prospective Observational Cohort Study -

Survival after colorectal cancer (CRC) diagnosis strongly depends on local tumor extent, lymph node involvement and the presence of distant metastases. However, there remains great inter-patient variability regarding treatment outcome. A combination of biochemical factors, histopathological features, genomic profile, environmental factors and other clinical factors are likely to influence prognosis and treatment effect, independent from tumor stage, but it is still unclear which, how, and to what extent these factors can influence tumor recurrence and mortality in both early stage (I-III) and late stage (IV) CRC, small bowel cancer and anal cancer.

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer

Detailed Description

Objectives

• 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.

• Study Type: Observational
• Enrollment (Estimated): 50000

Contacts and Locations

• Study Contact: Name: Miriam Koopman, MD, PhD; Email: m.koopman-6@umcutrecht.nl

Study Locations

• Netherlands
  • Alkmaar, Netherlands
    • Recruiting
    • Noordwest Ziekenhuisgroep
    • Contact: M.P. Hendriks
  • Almere, Netherlands
    • Recruiting
    • Flevoziekenhuis
    • Contact: D. Sommeijer
  • Amersfoort, Netherlands
    • Recruiting
    • Meander Medisch Centrum
    • Contact: J.M. van Dodewaard
  • Amstelveen, Netherlands
    • Recruiting
    • Ziekenhuis Amstelland
    • Contact: T. Kuiper
  • Amsterdam, Netherlands
    • Recruiting
    • OLVG
    • Contact: A.U.G van Lent
  • Amsterdam, Netherlands
    • Recruiting
    • Antoni van Leeuwenhoek
    • Contact: N.F.M. Kok
  • Amsterdam, Netherlands
    • Recruiting
    • VUMC
    • Contact: M.R. Meijerink
  • Amsterdam, Netherlands
    • Completed
    • AMC
  • Apeldoorn, Netherlands
    • Recruiting
    • Gelre Ziekenhuizen
    • Contact: P. van Duijvendijk
  • Arnhem, Netherlands
    • Recruiting
    • Rijnstate
    • Contact: T. van Voorthuizen
  • Assen, Netherlands
    • Recruiting
    • Wilhelmina Ziekenhuis Assen
    • Contact: P. Nieboer
  • Beverwijk, Netherlands
    • Recruiting
    • Rode Kruis Ziekenhuis
    • Contact: R.C. Rietbroek
  • Breda, Netherlands
    • Recruiting
    • Amphia ziekenhuis
    • Contact: J. Schreinemakers
  • Capelle aan den IJssel, Netherlands
    • Recruiting
    • IJsselland ziekenhuis
    • Contact: M. Vermaas
  • Delft, Netherlands
    • Recruiting
    • Reinier de Graaf
    • Contact: J.W.T. Dekker
  • Den Bosch, Netherlands
    • Recruiting
    • Jeroen Bosch Ziekenhuis
    • Contact: J.F.M. Pruijt
  • Den Haag, Netherlands
    • Recruiting
    • HagaZiekenhuis
    • Contact: D. Houtsma
  • Den Haag, Netherlands
    • Recruiting
    • HaaglandenMC
    • Contact: F.J.F. Jeurissen
  • Deventer, Netherlands
    • Recruiting
    • Deventer ziekenhuizen
    • Contact: K. Talsma
  • Dirksland, Netherlands
    • Recruiting
    • Van Weel-Bethesda Ziekenhuis
    • Contact: A.I. de Vos
  • Dordrecht, Netherlands
    • Recruiting
    • Albert Schweitzer Ziekenhuis
    • Contact: E.J.Th. Belt
  • Ede, Netherlands
    • Recruiting
    • Ziekenhuis Gelderse Vallei
    • Contact: A.W. Haringhuizen
  • Eindhoven, Netherlands
    • Recruiting
    • Máxima Medisch Centrum
    • Contact: L. Simkens
  • Eindhoven, Netherlands
    • Recruiting
    • Catharina Ziekenhuis
    • Contact: I.H.J.T. de Hingh
  • Enschede, Netherlands
    • Recruiting
    • Medisch Spectrum Twente
    • Contact: L. Mekenkamp
  • Goes, Netherlands
    • Recruiting
    • Admiraal de Ruyter Ziekenhuis
    • Contact: J. Jansen
  • Gorinchem, Netherlands
    • Recruiting
    • Rivas Beaterix Ziekenhuis
    • Contact: M.A. Davidis
  • Gouda, Netherlands
    • Recruiting
    • Groene Hart Ziekenhuis
    • Contact: M. Cloos-van Balen
  • Groningen, Netherlands
    • Recruiting
    • UMC Groningen
    • Contact: G. Hospers
  • Groningen, Netherlands
    • Recruiting
    • Martini Ziekenhuis
    • Contact: R.P. Veenstra
  • Haarlem, Netherlands
    • Recruiting
    • Spaarne Gasthuis
    • Contact: H.B.A.C. Stockmann
  • Hardenberg, Netherlands
    • Recruiting
    • Saxenburgh Groep
    • Contact: R. Blankenburgh
  • Harderwijk, Netherlands
    • Recruiting
    • St.Jansdal
    • Contact: A.P. Schouten van der Velden
  • Helmond, Netherlands
    • Recruiting
    • Elkerliek Ziekenhuis
    • Contact: J.A. Wegdam
  • Hengelo, Netherlands
    • Recruiting
    • Ziekenhuisgroep Twente
    • Contact: R. Hoekstra
  • Hilversum, Netherlands
    • Recruiting
    • Tergooi
    • Contact: A. van der Velden
  • Hoogeveen, Netherlands
    • Recruiting
    • TREANT Zorggroep
    • Contact: M. Tent
  • Hoorn, Netherlands
    • Recruiting
    • Dijklander ziekenhuis
    • Contact: D.J.A. Sonneveld
  • Leeuwarden, Netherlands
    • Recruiting
    • Medisch Centrum Leeuwarden
    • Contact: M.B. Polée
  • Leiden, Netherlands
    • Recruiting
    • Leids Universitair Medisch Centrum
    • Contact: K.C.M. Peeters
  • Leiden, Netherlands
    • Recruiting
    • Alrijne
    • Contact: L.E.A.M.M. Spierings
  • Maastricht, Netherlands
    • Recruiting
    • Maastricht UMC+
    • Contact: L.B.J. Valkenburg
  • Maastricht, Netherlands
    • Recruiting
    • Maastro
    • Contact: M. Berbée
  • Nieuwegein, Netherlands
    • Recruiting
    • St. Antonius Ziekenhuis
    • Contact: M. Los
  • Nijmegen, Netherlands
    • Recruiting
    • Radboud UMC
    • Contact: J.H.W. de Wilt
  • Nijmegen, Netherlands
    • Recruiting
    • Canisius Wilhelmina Ziekenhuis
    • Contact: J.J.B. Janssen
  • Oss, Netherlands
    • Recruiting
    • Bernhoven
    • Contact: R.W.M. Schrauwen
  • Roermond, Netherlands
    • Recruiting
    • Laurentius Ziekenhuis
    • Contact: G.H.E.J. Vijgen
  • Roosendaal, Netherlands
    • Recruiting
    • Bravis Ziekenhuis
    • Contact: F. Terheggen
  • Rotterdam, Netherlands
    • Recruiting
    • Erasmus MC
    • Contact: P.J. Tanis
  • Rotterdam, Netherlands
    • Recruiting
    • Maasstad Ziekenhuis
    • Contact: P.P.L.O Coene
  • Rotterdam, Netherlands
    • Recruiting
    • Franciscus Gasthuis & Vlietland
    • Contact: M. Verseveld
  • Rotterdam, Netherlands
    • Recruiting
    • Ikazia Ziekenhuis
    • Contact: W.J. Vles
  • Sittard, Netherlands
    • Recruiting
    • Zuyderland Medisch Centrum
    • Contact: F. Erdkamp
  • Sneek, Netherlands
    • Recruiting
    • Antonius Ziekenhuis
    • Contact: H. van Cruijsen
  • Terneuzen, Netherlands
    • Recruiting
    • ZorgSaam
    • Contact: M.P.S. Sie
  • Tiel, Netherlands
    • Recruiting
    • Ziekenhuis Rivierenland
    • Contact: M. Tjin-A-Ton
  • Tilburg, Netherlands
    • Recruiting
    • Elisabeth-TweeSteden Ziekenhuis
    • Contact: D.D.E Zimmerman
  • Utrecht, Netherlands
    • Recruiting
    • UMC Utrecht
    • Contact: Miriam Koopman
    • Principal Investigator: Miriam Koopman
    • Principal Investigator: Lenny HM Verkooijen
  • Utrecht, Netherlands
    • Recruiting
    • Diakonessenhuis
    • Contact: A. Schiphorst
  • Venlo, Netherlands
    • Recruiting
    • VieCuri Medisch Centrum
    • Contact: J. Konsten
  • Weert, Netherlands
    • Recruiting
    • St. Jans Gasthuis
    • Contact: N.A.J.B. Peters
  • Zwolle, Netherlands
    • Recruiting
    • Isala
    • Contact: J.W. de Groot

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients diagnosed with colorectal, small bowel and anal cancer, who are recently diagnosed, have a strong suspicion without pathological confirmation or are currently under treatment or follow up in one of the participating hospitals will be asked to participate in this cohort study.

Description

Inclusion Criteria:

• Age ≥ 18 years
• Histological proof of colorectal, small bowel and anal cancer, or a strong suspicion after imaging.
• Informed consent for longitudinal observational data collection.

Exclusion Criteria:

• Mentally incompetent patients.

Participation of patients to the PLCRC project does not exclude participation in any other ongoing or future study.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression free survival	up to 10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival		up to 10 years
Disease free survival		up to 10 years
Health related quality of life	measured by EORTC QLQ questionnaire	3, 6, 12, 24, 36, 48 months
Grade 3/4 (serious) adverse events		3 months
Work Ability Index (WAI)		3, 6, 12, 24, 36, 48 months

Collaborators and Investigators

• Sponsor: Dutch Colorectal Cancer Group
• Investigators: Principal Investigator: Miriam Koopman, MD, PhD, UMC Utrecht

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2013
• Primary Completion (Estimated): January 1, 2050
• Study Completion (Estimated): January 1, 2051

Study Registration Dates

• First Submitted: August 7, 2013
• First Submitted That Met QC Criteria: February 21, 2014
• First Posted (Estimated): February 25, 2014

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 12-510