Clinical trial · Observational
Prospective Data Collection Initiative on Colorectal Cancer
Prospective Data Collection Initiative on Colorectal Cancer - a Prospective Observational Cohort Study -
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
- up to 10 years
Secondary outcomes (5)
- measure
- Health related quality of life
- timeFrame
- 3, 6, 12, 24, 36, 48 months
- description
- measured by EORTC QLQ questionnaire
- measure
- Grade 3/4 (serious) adverse events
- timeFrame
- 3 months
- measure
- Disease free survival
- timeFrame
- up to 10 years
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (3)
- DERIVEDPennings 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. PMID 39358881
- DERIVEDvan 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. PMID 38700376
- DERIVEDSmit 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 38079324