Prospective Data Collection Initiative on Colorectal Cancer

Recruiting

• 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.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-08-07
• Study First Submitted QC: 2014-02-21
• Study First Posted: 2014-02-25
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-17
• Primary Completion: 2050-01
• Study Completion: 2051-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50000

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

Trial Locations

Locations (67)

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

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