Hereditary nonpolyposis colorectal cancer

Cancer Family Syndrome; Colon Cancer, Familial Nonpolyposis; Familial nonpolyposis colon cancer; HNPCC; Lynch Syndrome

Clinical Trial: Implementation of a New Strategy to Identify HNPCC Patients

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Purpose
Eligibility
Location and Contact Information
More Information

This study is not yet open for patient recruitment.
Verified by Radboud University August 2005

Sponsors and Collaborators:	Radboud University ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:	Radboud University
ClinicalTrials.gov Identifier:	NCT00141466

Purpose

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.

Condition	Intervention
Colorectal Neoplasms Hereditary Nonpolyposis Colorectal Cancer	Behavior: Education for professionals Behavior: Distribution of educational materials Behavior: Feedback for professionals Behavior: Reminders for professionals

MedlinePlus related topics: Cancer; Cancer Alternative Therapies; Colorectal Cancer; Genetic Disorders
Genetics Home Reference related topics: hereditary nonpolyposis colorectal cancer

Study Type: Interventional
Study Design: Educational/Counseling/Training, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

Official Title: Cost Effectiveness of Two Different Implementation Procedures to Change Clinicians Practice Roles in the Detection of Hereditary Colorectal Cancer

Further Study Details:

Primary Outcomes: Efficacy of inclusion of eligible CRC-patients for MSI testing by pathologists.; Efficacy of referral of patients who are MSI positive to a clinical geneticist by surgeons.
Secondary Outcomes: Experiences with and acceptance of changed physician practice roles by patients and clinicians.; Cost efficacy of the implementation procedures.
Expected Total Enrollment: 360

Study start: September 2005; Expected completion: January 2008
Last follow-up: July 2007; Data entry closure: July 2007

The Radboud University Nijmegen Medical Centre developed a new method to identify patients with HNPCC. This method appeared cost-effective and feasible. Using this new method 70% of the HNPCC patients will be identified as compared to less than 30% when the current method is used. However, this new method does not implement itself; large gaps exists between best evidence and daily practice. This study will compare an intensive strategy, consisting of distribution of educational materials, education, feedback and reminders, with a minimal strategy, only consisting of distribution of a critical care pathway. The aim is to find the most cost-effective strategy to implement the new method to identify patients with HNPCC in the Netherlands.

Eligibility

Genders Eligible for Study: Both

Criteria

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

Exclusion Criteria:

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier NCT00141466

Lucy I Overbeek, MSc +31-24-3613946 l.overbeek@antrg.umcn.nl
Nicoline Hoogerbrugge, MD PhD +31-24-3613946 n.hoogerbrugge@antrg.umcn.nl

Netherlands
St. Elisabeth Ziekenhuis, Tilburg, Netherlands

Anneke van der Wurff, MD PhD

Laboratorium voor pathologie Oost-Nederland, ENSCHEDE, Netherlands

Sietske Riemersma, MD

Elkerliek Ziekenhuis, HELMOND, Netherlands

Cilia M Ferrier, MD PhD

Jeroen Bosch Ziekenhuis, ''''s-Hertogenbosch, Netherlands

Stan J Ketelaars, MD

Ziekenhuis Rijnstate, ARNHEM, Netherlands

Jos Meijer, MD

Canisius Wilhelmina Ziekenhuis, Nijmegen, Netherlands

Erik Thunnissen, MD PhD

Stichting laboratoria voor pathologische anatomie en medische microbiologie, Eindhoven, Netherlands

Ineke van Lijnschoten, MD PhD

Laboratorium Volksgezondheid Friesland, Leeuwarden, Netherlands

Joris J Grond, MD PhD

Martini Ziekenhuis, Groningen, Netherlands

A Tiebosch, MD PhD

Pathologie laboratorium voor Dordrecht, Dordrecht, Netherlands

Pieter J Westenend, MD PhD

HagaZiekenhuis, Den Haag, Netherlands

Paul Blok, MD PhD

Medisch Centrum Rijnmond Zuid, Rotterdam, Netherlands

Sonja Henzen, MD PhD

Study chairs or principal investigators

Nicoline Hoogerbrugge, MD PhD, Principal Investigator, Department of Human Genetics, Radboud University Nijmegen Medical Center
Rosella P Hermens, MSc PhD, Principal Investigator, Center of Quality of Care Research, Radboud University Nijmegen Medical Center

More Information

Publications

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.

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.

Study ID Numbers: MIPA-2005; ZonMw nr. 945-14-107
Last Updated: August 31, 2005
Record first received: August 31, 2005
ClinicalTrials.gov Identifier: NCT00141466
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
ClinicalTrials.gov processed this record on 2005-09-06

Source: ClinicalTrials.gov
Cache Date: September 7, 2005

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Implementation of a New Strategy to Identify HNPCC Patients - Article

General Topics A-Z

Hereditary nonpolyposis colorectal cancer

Cancer Family Syndrome; Colon Cancer, Familial Nonpolyposis; Familial nonpolyposis colon cancer; HNPCC; Lynch Syndrome

Clinical Trial: Implementation of a New Strategy to Identify HNPCC Patients

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Purpose

Eligibility

Location and Contact Information

More Information

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Implementation of a New Strategy to Identify HNPCC Patients - Article

General Topics A-Z

Hereditary nonpolyposis colorectal cancer

Cancer Family Syndrome; Colon Cancer, Familial Nonpolyposis; Familial nonpolyposis colon cancer; HNPCC; Lynch Syndrome

Clinical Trial: Implementation of a New Strategy to Identify HNPCC Patients

Jump to Section

Purpose

Eligibility

Location and Contact Information

More Information

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Limited Time Offer!!!

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