Prospective Data Collection Initiative on Colorectal Cancer
PLCRC
1 other identifier
observational
50,000
1 country
67
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2013
Longer than P75 for all trials
67 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 7, 2013
CompletedFirst Posted
Study publicly available on registry
February 25, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2050
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2051
March 17, 2025
March 1, 2025
36.7 years
August 7, 2013
March 13, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Progression free survival
up to 10 years
Secondary Outcomes (5)
Health related quality of life
3, 6, 12, 24, 36, 48 months
Grade 3/4 (serious) adverse events
3 months
Disease free survival
up to 10 years
Overall survival
up to 10 years
Work Ability Index (WAI)
3, 6, 12, 24, 36, 48 months
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- Mentally incompetent patients.
- Participation of patients to the PLCRC project does not exclude participation in any other ongoing or future study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (67)
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
Frisius MC Leeuwarden
Leeuwarden, Netherlands
Alrijne
Leiden, 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
Ikazia Ziekenhuis
Rotterdam, Netherlands
Maasstad Ziekenhuis
Rotterdam, Netherlands
Zuyderland Medisch Centrum
Sittard, Netherlands
Antonius Ziekenhuis
Sneek, Netherlands
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
Related Publications (1)
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.
PMID: 38079324DERIVED
Biospecimen
Blood and tumor tissue will be stored.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Miriam Koopman, MD, PhD
UMC Utrecht
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 50 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2013
First Posted
February 25, 2014
Study Start
May 1, 2013
Primary Completion (Estimated)
January 1, 2050
Study Completion (Estimated)
January 1, 2051
Last Updated
March 17, 2025
Record last verified: 2025-03