The prospective data collection initiative on on small bowel, colorectal and anal cancer - a prospective observational cohort study.

Survival after cancer 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) colorectal cancer
(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 to
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 to 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 to 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.
We here propose to initiate such a study in patients with CRC, small bowel
cancer and anal cancer in the Netherlands. If successful, it is expected that
this study will be adopted to other tumor types as well..

The main objectives of this project are:

- To start a prospective observational cohort study of patients who have been
diagnosed with CRC, small bowel and anal cancer and follow them from time of
diagnosis until death.

- To prospectively collect data on medical history, serious comorbidities,
basic physical examination, imaging results, pathology results, tumor
characteristics, treatment, treatment outcomes, hospital stays, interventions
and adverse events.

- To store tumor tissue material, obtained during routine practice, for future
research and to collect and store blood samples for observational and future
reseach.

- To provide more accurate data on the treatment and clinical/ patient reported
outcomes of CRC, small bowel and anal cancer in normal daily clinical care. To
create a continuous basis for a large variety of research purposes including:

A. Prognostic and predictive research
B. Biological research and (epi)genetic research
C. Studies that compare new therapies in a target population
according to the Trials within Cohorts (TwiCs) design.
D. Health care policies and cost-effectiveness studies

prospective observational cohort study

Since this is an observational study there are no additional risks associated
with participation. Clinical (outcome) parameters will be collected during
routine care and derived from medical charts. Consenting patients will be asked
to fill out standard questionnaires.
If a patient gives informed consent to be approached for possible future
studies within this project, he/she can be invited to participate in one or
more studies within this project. Patients who consent to participate in the
TwiCs part of the project will be informed that their data will be used for
comparative evaluation of safety and effectiveness of new interventions. They
are also informed about the possibility that they may be offered an
experimental intervention, which they may refuse. They are also informed about
the fact that if they are not selected for a certain experimental intervention,
and therefore are part of the control arm, they may be (temporarily) ineligible
for some future experimental interventions.
In any instance, patients will never be withheld from standard, evidence-based
treatments.