Prospective Data Collection Initiative on Colorectal Cancer
- Conditions
- Colorectal Cancer
- Registration Number
- NCT02070146
- Lead Sponsor
- Dutch Colorectal Cancer Group
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50000
- 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.
- Mentally incompetent patients.
Participation of patients to the PLCRC project does not exclude participation in any other ongoing or future study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival up to 10 years
- Secondary Outcome Measures
Name Time Method Disease free survival up to 10 years Work Ability Index (WAI) 3, 6, 12, 24, 36, 48 months Grade 3/4 (serious) adverse events 3 months Health related quality of life 3, 6, 12, 24, 36, 48 months measured by EORTC QLQ questionnaire
Overall survival up to 10 years
Trial Locations
- Locations (67)
Rivas Beaterix Ziekenhuis
🇳🇱Gorinchem, Netherlands
Noordwest Ziekenhuisgroep
🇳🇱Alkmaar, Netherlands
Flevoziekenhuis
🇳🇱Almere, 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
Jeroen Bosch Ziekenhuis
🇳🇱Den Bosch, Netherlands
Haaglanden MC
🇳🇱Den Haag, Netherlands
HagaZiekenhuis
🇳🇱Den Haag, 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
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
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