Prospective Data Collection Initiative on Colorectal Cancer

Colorectal Cancer Clinical Trial

— PLCRC  

Official title:

Prospective Data Collection Initiative on Colorectal Cancer - a Prospective Observational Cohort Study -

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02070146
• Other study ID #: 12-510
• Status: Recruiting
• Start date: May 2013
• Est. completion date: January 2051

Study information

• Verified date: February 2024
• Source: Dutch Colorectal Cancer Group
• Contact: Miriam Koopman, MD, PhD
• Email: m.koopman-6[@]umcutrecht.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 50000
• Est. completion date: January 2051
• Est. primary completion date: January 2050
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
Netherlands	Noordwest Ziekenhuisgroep	Alkmaar
Netherlands	Flevoziekenhuis	Almere
Netherlands	Meander Medisch Centrum	Amersfoort
Netherlands	Ziekenhuis Amstelland	Amstelveen
Netherlands	AMC	Amsterdam
Netherlands	Antoni van Leeuwenhoek	Amsterdam
Netherlands	OLVG	Amsterdam
Netherlands	VUmc	Amsterdam
Netherlands	Gelre Ziekenhuizen	Apeldoorn
Netherlands	Rijnstate	Arnhem
Netherlands	Wilhelmina Ziekenhuis Assen	Assen
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	HaaglandenMC	Den Haag
Netherlands	HagaZiekenhuis	Den Haag
Netherlands	Deventer Ziekenhuizen	Deventer
Netherlands	Van Weel-Bethesda Ziekenhuis	Dirksland
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	Admiraal De Ruyter Ziekenhuis	Goes
Netherlands	Rivas Beaterix Ziekenhuis	Gorinchem
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	Elkerliek Ziekenhuis	Helmond
Netherlands	Ziekenhuisgroep Twente	Hengelo
Netherlands	Tergooi	Hilversum
Netherlands	Treant Zorggroep	Hoogeveen
Netherlands	Dijklander Ziekenhuis	Hoorn
Netherlands	Medisch Centrum 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	Isala	Zwolle

Sponsors (1)

Lead Sponsor	Collaborator
Dutch Colorectal Cancer Group

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival		up to 10 years
Secondary	Health related quality of life	measured by EORTC QLQ questionnaire	3, 6, 12, 24, 36, 48 months
Secondary	Grade 3/4 (serious) adverse events		3 months
Secondary	Disease free survival		up to 10 years
Secondary	Overall survival		up to 10 years
Secondary	Work Ability Index (WAI)		3, 6, 12, 24, 36, 48 months