Colorectal CancerPLCRCNCT02070146
Prospective Data Collection Initiative on Colorectal Cancer
An observational study of Colorectal Cancer, run by Dutch Colorectal Cancer Group at 70 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- How many people
- 50,000 participants
- Where
- 70 sitesNetherlands
- Study dates
- May 2013to Jan 2051
- How long will I take part?
- 50 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Mentally incompetent patients.
- Participation of patients to the PLCRC project does not exclude participation in any other ongoing or future study.
Trial locations and contacts
70 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Miriam Koopman, MD, PhD contact
70 sites in 1 country
Netherlands70 sites, 70 recruiting
- Recruiting
Jeroen Bosch Ziekenhuis
's-Hertogenbosch
M.L. Wumkes
- Recruiting
Noordwest Ziekenhuisgroep
Alkmaar
M.P. Hendriks
- Recruiting
Flevoziekenhuis
Almere Stad
D. Sommeijer
- Recruiting
Meander Medisch Centrum
Amersfoort
J.M. van Dodewaard
- Recruiting
Ziekenhuis Amstelland
Amstelveen
T. Kuiper
- Recruiting
Antoni van Leeuwenhoek
Amsterdam
N.F.M. Kok
- Recruiting
OLVG
Amsterdam
A.U.G van Lent
- Recruiting
VUmc
Amsterdam
M.R. Meijerink
- Recruiting
Gelre Ziekenhuizen
Apeldoorn
P. van Duijvendijk
- Recruiting
Rijnstate
Arnhem
T. van Voorthuizen
- Recruiting
Wilhelmina Ziekenhuis Assen
Assen
P. Nieboer
- Recruiting
Maasziekenhuis Pantein
Beugen
M. Blussé, 00310485845335, m.blusse@pantein.nl
- Recruiting
Rode Kruis Ziekenhuis
Beverwijk
A. Goosens
- Recruiting
Amphia ziekenhuis
Breda
J. Schreinemakers
- Recruiting
IJsselland Ziekenhuis
Capelle aan den IJssel
M. Vermaas
- Recruiting
Reinier de Graaf
Delft
J.W.T. Dekker
- Recruiting
Deventer Ziekenhuizen
Deventer
K. Talsma
- Recruiting
Van Weel-Bethesda Ziekenhuis
Dirksland
A. Dietvorst
- Recruiting
Slingeland Ziekenhuis
Doetinchem
R.A.W. van de Wetering
- Recruiting
Albert Schweitzer Ziekenhuis
Dordrecht
E.J.Th. Belt
- Recruiting
Ziekenhuis Nij Smellinghe
Drachten
- Recruiting
Ziekenhuis Gelderse Vallei
Ede
A.W. Haringhuizen
- Recruiting
Catharina Ziekenhuis
Eindhoven
I.H.J.T. de Hingh
- Recruiting
Maxima Medisch Centrum
Eindhoven
L. Simkens
- Recruiting
Medisch Spectrum Twente
Enschede
L. Mekenkamp
- Recruiting
Anna Ziekenhuis
Geldrop
J.M.W.E. Willems, 0031402864830, Research.oncologie@st-anna.nl
- Recruiting
Admiraal De Ruyter Ziekenhuis
Goes
J. Jansen
- Recruiting
Rivas Beaterix Ziekenhuis
Gorinchem
M.A. Davidis
- Recruiting
Groene Hart Ziekenhuis
Gouda
M. Cloos-van Balen
- Recruiting
Martini Ziekenhuis
Groningen
R.P. Veenstra
- Recruiting
Ommelander Ziekenhuis
Groningen
S.H.E.M. Clermonts
- Recruiting
UMC Groningen
Groningen
G. Hospers
- Recruiting
Spaarne Gasthuis
Haarlem
H.B.A.C. Stockmann
- Recruiting
Saxenburgh Groep
Hardenberg
R. Blankenburgh
- Recruiting
St.Jansdal
Harderwijk
A.P. Schouten van der Velden
- Recruiting
Frisius MC Heerenveen
Heerenveen
J. de Boer
- Recruiting
Elkerliek Ziekenhuis
Helmond
J.A. Wegdam
- Recruiting
Ziekenhuisgroep Twente
Hengelo
R. Hoekstra
- Recruiting
Tergooi
Hilversum
A. van der Velden
- Recruiting
Treant Zorggroep
Hoogeveen
M. Tent
- Recruiting
Dijklander Ziekenhuis
Hoorn
D.J.A. Sonneveld
- Recruiting
Frisius MC Leeuwarden
Leeuwarden
M.B. Polée
- Recruiting
Alrijne
Leiden
L.E.A.M.M. Spierings
- Recruiting
Leids Universitair Medisch Centrum
Leiden
K.C.M. Peeters
- Recruiting
Maastricht UMC+
Maastricht
L.B.J. Valkenburg
- Recruiting
MAASTRO
Maastricht
M. Berbée
- Recruiting
St. Antonius ziekenhuis
Nieuwegein
M. Los
- Recruiting
Canisius Wilhelmina Ziekenhuis
Nijmegen
J.J.B. Janssen
- Recruiting
Radboud UMC
Nijmegen
J.H.W. de Wilt
- Recruiting
Bernhoven
Oss
R.W.M. Schrauwen
- Recruiting
Laurentius Ziekenhuis
Roermond
G.H.E.J. Vijgen
- Recruiting
Bravis ziekenhuis
Roosendaal
F. Terheggen
- Recruiting
Erasmus MC
Rotterdam
P.J. Tanis
- Recruiting
Franciscus Gasthuis & Vlietland
Rotterdam
M. Verseveld
- Recruiting
Ikazia Ziekenhuis
Rotterdam
W.J. Vles
- Recruiting
Maasstad Ziekenhuis
Rotterdam
P.P.L.O Coene
- Recruiting
Zuyderland Medisch Centrum
Sittard
B. Scholtes
- Recruiting
Antonius Ziekenhuis
Sneek
H. van Cruijsen
- Recruiting
ZorgSaam
Terneuzen
M.P.S. Sie
- Recruiting
Haaglanden MC
The Hague
F.J.F. Jeurissen
- Recruiting
HagaZiekenhuis
The Hague
D. Houtsma
- Recruiting
Ziekenhuis Rivierenland
Tiel
M. Tjin-A-Ton
- Recruiting
Elisabeth-TweeSteden Ziekenhuis
Tilburg
D.D.E Zimmerman
- Recruiting
Diakonessenhuis
Utrecht
A. Schiphorst
- Recruiting
UMC Utrecht
Utrecht
Miriam Koopman
Miriam Koopman
- Recruiting
VieCuri Medisch Centrum
Venlo
J. Konsten
- Recruiting
St. Jans Gasthuis
Weert
N.A.J.B. Peters
- Recruiting
Streekziekenhuis Koningin Beatrix
Winterswijk
L. van Steensel
- Recruiting
Zaans Medisch Centrum
Zaandam
G. Musters
- Recruiting
Isala
Zwolle
J.W. de Groot
About this study
Official title: 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.
Read the 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:
- 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
- Colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: up to 10 years
Secondary outcomes (5)
Health related quality of life
measured by EORTC QLQ questionnaire
Measured: 3, 6, 12, 24, 36, 48 months
Grade 3/4 (serious) adverse events
Measured: 3 months
Disease free survival
Measured: up to 10 years
Overall survival
Measured: up to 10 years
Work Ability Index (WAI)
Measured: 3, 6, 12, 24, 36, 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study startMay 2013
- Primary completionJan 2050 (estimated)
- Study completionJan 2051 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50,000 participants (estimated)
- Target duration
- 50 Years
Sponsor and investigators
- Lead sponsor
- Dutch Colorectal Cancer Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Miriam Koopman, MD, PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02070146
- Sponsor's protocol ID
- 12-510
- Acronym
- PLCRC
- Status last verified
- Jun 2026
- First submitted
- 7 Aug 2013
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Pennings AJ, Vink GR, van Kuijk S, Melenhorst J, Beets GL, May AM, Breukink SO. Quality of life and functional outcome of rectal cancer patients: A prospective cohort study. Colorectal Dis. 2024 Nov;26(11):1892-1902. doi: 10.1111/codi.17181. Epub 2024 Oct 2.
PubMed 39358881van Lanen AS, Kok DE, Wesselink E, Derksen JWG, May AM, Smit KC, Koopman M, de Wilt J, Kampman E, van Duijnhoven FJB; COLON and PLCRC studies. Associations between low- and high-fat dairy intake and recurrence risk in people with stage I-III colorectal cancer differ by sex and primary tumour location. Int J Cancer. 2024 Sep 1;155(5):828-838. doi: 10.1002/ijc.34959. Epub 2024 May 3.
PubMed 38700376Smit 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.
PubMed 38079324
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Data Collection Initiative on Colorectal Cancer - a Prospective Observational Cohort Study -
- ClinicalTrials.gov ID
- NCT02070146
- Acronym / sponsor ID
- PLCRC / 12-510
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- Dutch Colorectal Cancer GroupUniversity, hospital or other
- Study start
- May 2013 (actual)
- Primary completion
- Jan 2050 (estimated)
- Study completion
- Jan 2051 (estimated)
- First posted
- 25 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 50 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Mentally incompetent patients.
- Participation of patients to the PLCRC project does not exclude participation in any other ongoing or future study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression free survival
Time frame: up to 10 years
5 secondary outcomes
Health related quality of life
Time frame: 3, 6, 12, 24, 36, 48 months
Grade 3/4 (serious) adverse events
Time frame: 3 months
Disease free survival
Time frame: up to 10 years
Overall survival
Time frame: up to 10 years
Work Ability Index (WAI)
Time frame: 3, 6, 12, 24, 36, 48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Derived from this study: PubMed 39358881Pennings AJ, Vink GR, van Kuijk S, Melenhorst J, Beets GL, May AM, Breukink SO. Quality of life and functional outcome of rectal cancer patients: A prospective cohort study. Colorectal Dis. 2024 Nov;26(11):1892-1902. doi: 10.1111/codi.17181. Epub 2024 Oct 2.
- Derived from this study: PubMed 38700376van Lanen AS, Kok DE, Wesselink E, Derksen JWG, May AM, Smit KC, Koopman M, de Wilt J, Kampman E, van Duijnhoven FJB; COLON and PLCRC studies. Associations between low- and high-fat dairy intake and recurrence risk in people with stage I-III colorectal cancer differ by sex and primary tumour location. Int J Cancer. 2024 Sep 1;155(5):828-838. doi: 10.1002/ijc.34959. Epub 2024 May 3.
- Derived from this study: PubMed 38079324Smit 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Miriam Koopman, MD, PhD contact
Miriam Koopman, MD, PhD principal investigator
UMC Utrecht
70 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Dutch Colorectal Cancer Group at 70 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 70 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miriam Koopman, MD, PhD (m.koopman-6@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: up to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02070146, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.