Colorectal Neoplasms Clinical Trial
Official title:
Cost Effectiveness of Two Different Implementation Procedures to Change Clinicians Practice Roles in the Detection of Hereditary Colorectal Cancer
The purpose of this study is to compare two different strategies to implement a new method to identify patients with HNPCC, which appeared cost-effective and feasible. The effectiveness, costs and feasibility of both of the implementation strategies will be assessed.
Status | Recruiting |
Enrollment | 360 |
Est. completion date | July 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Colorectal cancer before the age of 50 years - Second colorectal cancer at any age - Colorectal cancer and other HNPCC associated extracolonic cancer irrespective of age at diagnosis - Adenoma with high grade dysplasia diagnosed before the age of 40 years |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind
Country | Name | City | State |
---|---|---|---|
Netherlands | Jeroen Bosch Ziekenhuis | 's-Hertogenbosch | |
Netherlands | Meander Medisch Centrum | Amersfoort | |
Netherlands | Ziekenhuis Rijnstate | Arnhem | |
Netherlands | HagaZiekenhuis | Den Haag | |
Netherlands | Pathologie laboratorium voor Dordrecht | Dordrecht | |
Netherlands | Stichting laboratoria voor pathologische anatomie en medische microbiologie | Eindhoven | |
Netherlands | Laboratorium voor pathologie Oost-Nederland | Enschede | |
Netherlands | Martini Ziekenhuis | Groningen | |
Netherlands | Elkerliek Ziekenhuis | Helmond | |
Netherlands | Laboratorium Volksgezondheid Friesland | Leeuwarden | |
Netherlands | Canisius Wilhelmina Ziekenhuis | Nijmegen | |
Netherlands | Medisch Centrum Rijnmond Zuid | Rotterdam | |
Netherlands | St. Elisabeth Ziekenhuis | Tilburg |
Lead Sponsor | Collaborator |
---|---|
Radboud University | ZonMw: The Netherlands Organisation for Health Research and Development |
Netherlands,
de Bruin JH, Kievit W, Ligtenberg MJ, Nagengast FM, Adang EM, Ruers TJ, Kleibeuker JH, Sijmons RH, van Krieken JH, Hoogerbrugge N. [More hereditary intestinal cancer can be detected if patients with colorectal carcinoma that are selected by the pathologist are examined for microsatellite instability]. Ned Tijdschr Geneeskd. 2005 Aug 6;149(32):1792-8. Dutch. — View Citation
Kievit W, de Bruin JH, Adang EM, Severens JL, Kleibeuker JH, Sijmons RH, Ruers TJ, Nagengast FM, Vasen HF, van Krieken JH, Ligtenberg MJ, Hoogerbrugge N. Cost effectiveness of a new strategy to identify HNPCC patients. Gut. 2005 Jan;54(1):97-102. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy of inclusion of eligible CRC-patients for MSI testing by pathologists. | |||
Primary | Efficacy of referral of patients who are MSI positive to a clinical geneticist by surgeons. | |||
Secondary | Experiences with and acceptance of changed physician practice roles by patients and clinicians. | |||
Secondary | Cost efficacy of the implementation procedures. |
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