Clinical trial NCT02070146: Prospective Data Collection Initiative on Colorectal Cancer
Official title: Prospective Data Collection Initiative on Colorectal Cancer - a Prospective Observational Cohort Study -
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer
Lead sponsor: Dutch Colorectal Cancer Group
Sponsor class: OTHER
First posted: 2014-02-25
Enrollment: 50000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Progression free survival
timeFrame: up to 10 years
Secondary outcomes:
measure: Health related quality of life
timeFrame: 3, 6, 12, 24, 36, 48 months
measure: Grade 3/4 (serious) adverse events
timeFrame: 3 months
measure: Disease free survival
timeFrame: up to 10 years
measure: Overall survival
timeFrame: up to 10 years
measure: Work Ability Index (WAI)
timeFrame: 3, 6, 12, 24, 36, 48 months
Other outcomes:
Locations:
city: Alkmaar
country: Netherlands
facility: Noordwest Ziekenhuisgroep
city: Almere
country: Netherlands
facility: Flevoziekenhuis
city: Amersfoort
country: Netherlands
facility: Meander Medisch Centrum
city: Amstelveen
country: Netherlands
facility: Ziekenhuis Amstelland
city: Amsterdam
country: Netherlands
facility: Antoni van Leeuwenhoek
city: Amsterdam
country: Netherlands
facility: OLVG
city: Amsterdam
country: Netherlands
facility: VUmc
city: Apeldoorn
country: Netherlands
facility: Gelre Ziekenhuizen
city: Arnhem
country: Netherlands
facility: Rijnstate
city: Assen
country: Netherlands
facility: Wilhelmina Ziekenhuis Assen
city: Beugen
country: Netherlands
facility: Maasziekenhuis Pantein
city: Beverwijk
country: Netherlands
facility: Rode Kruis Ziekenhuis
city: Breda
country: Netherlands
facility: Amphia ziekenhuis
city: Capelle aan den IJssel
country: Netherlands
facility: IJsselland Ziekenhuis
city: Delft
country: Netherlands
facility: Reinier de Graaf
city: Den Bosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Den Haag
country: Netherlands
facility: Haaglanden MC
city: Den Haag
country: Netherlands
facility: HagaZiekenhuis
city: Deventer
country: Netherlands
facility: Deventer Ziekenhuizen
city: Dirksland
country: Netherlands
facility: Van Weel-Bethesda Ziekenhuis
city: Doetinchem
country: Netherlands
facility: Slingeland Ziekenhuis
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis
city: Ede
country: Netherlands
facility: Ziekenhuis Gelderse Vallei
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Eindhoven
country: Netherlands
facility: Maxima Medisch Centrum
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Geldrop
country: Netherlands
facility: Anna Ziekenhuis
city: Goes
country: Netherlands
facility: Admiraal De Ruyter Ziekenhuis
city: Gorinchem
country: Netherlands
facility: Rivas Beaterix Ziekenhuis
city: Gouda
country: Netherlands
facility: Groene Hart Ziekenhuis
city: Groningen
country: Netherlands
facility: Martini Ziekenhuis
city: Groningen
country: Netherlands
facility: UMC Groningen
city: Haarlem
country: Netherlands
facility: Spaarne Gasthuis
city: Hardenberg
country: Netherlands
facility: Saxenburgh Groep
city: Harderwijk
country: Netherlands
facility: St.Jansdal
city: Heerenveen
country: Netherlands
facility: Frisius MC Heerenveen
city: Helmond
country: Netherlands
facility: Elkerliek Ziekenhuis
city: Hengelo
country: Netherlands
facility: Ziekenhuisgroep Twente
city: Hilversum
country: Netherlands
facility: Tergooi
city: Hoogeveen
country: Netherlands
facility: Treant Zorggroep
city: Hoorn
country: Netherlands
facility: Dijklander Ziekenhuis
city: Leeuwarden
country: Netherlands
facility: Frisius MC Leeuwarden
city: Leiden
country: Netherlands
facility: Alrijne
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum
city: Maastricht
country: Netherlands
facility: Maastricht UMC+
city: Maastricht
country: Netherlands
facility: MAASTRO
city: Nieuwegein
country: Netherlands
facility: St. Antonius ziekenhuis
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelmina Ziekenhuis
city: Nijmegen
country: Netherlands
facility: Radboud UMC
city: Oss
country: Netherlands
facility: Bernhoven
city: Roermond
country: Netherlands
facility: Laurentius Ziekenhuis
city: Roosendaal
country: Netherlands
facility: Bravis ziekenhuis
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Rotterdam
country: Netherlands
facility: Franciscus Gasthuis & Vlietland
city: Rotterdam
country: Netherlands
facility: Ikazia Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis
city: Sittard
country: Netherlands
facility: Zuyderland Medisch Centrum
city: Sneek
country: Netherlands
facility: Antonius Ziekenhuis
city: Terneuzen
country: Netherlands
facility: ZorgSaam
city: Tiel
country: Netherlands
facility: Ziekenhuis Rivierenland
city: Tilburg
country: Netherlands
facility: Elisabeth-TweeSteden Ziekenhuis
city: Utrecht
country: Netherlands
facility: Diakonessenhuis
city: Utrecht
country: Netherlands
facility: UMC Utrecht
city: Venlo
country: Netherlands
facility: VieCuri Medisch Centrum
city: Weert
country: Netherlands
facility: St. Jans Gasthuis
city: Zaandam
country: Netherlands
facility: Zaans Medisch Centrum
city: Zwolle
country: Netherlands
facility: Isala
Study officials:
affiliation: UMC Utrecht
name: Miriam Koopman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: