MedDataX Logo

Implementation of a New Strategy to Identify HNPCC Patients

NCT ID: NCT00141466

Last Updated: 2008-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2007-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Neoplasms Hereditary Nonpolyposis Colorectal Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Hereditary colorectal cancer Microsatellite instability Physician roles Health care implementation Intervention

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Education for professionals

Intervention Type BEHAVIORAL

Distribution of educational materials

Intervention Type BEHAVIORAL

Feedback for professionals

Intervention Type BEHAVIORAL

Reminders for professionals

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nicoline Hoogerbrugge, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Human Genetics, Radboud University Nijmegen Medical Center

Rosella P Hermens, MSc PhD

Role: PRINCIPAL_INVESTIGATOR

Center of Quality of Care Research, Radboud University Nijmegen Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, , Netherlands

Site Status RECRUITING

Meander Medisch Centrum

Amersfoort, , Netherlands

Site Status RECRUITING

Ziekenhuis Rijnstate

Arnhem, , Netherlands

Site Status RECRUITING

Pathologie laboratorium voor Dordrecht

Dordrecht, , Netherlands

Site Status RECRUITING

Stichting laboratoria voor pathologische anatomie en medische microbiologie

Eindhoven, , Netherlands

Site Status RECRUITING

Laboratorium voor pathologie Oost-Nederland

Enschede, , Netherlands

Site Status RECRUITING

Martini Ziekenhuis

Groningen, , Netherlands

Site Status RECRUITING

Elkerliek Ziekenhuis

Helmond, , Netherlands

Site Status RECRUITING

Laboratorium Volksgezondheid Friesland

Leeuwarden, , Netherlands

Site Status RECRUITING

Canisius Wilhelmina Ziekenhuis

Nijmegen, , Netherlands

Site Status RECRUITING

Medisch Centrum Rijnmond Zuid

Rotterdam, , Netherlands

Site Status RECRUITING

HagaZiekenhuis

The Hague, , Netherlands

Site Status RECRUITING

St. Elisabeth Ziekenhuis

Tilburg, , Netherlands

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Lucy I Overbeek, MSc

Role: CONTACT

Phone: +31-24-3613946

Email: [email protected]

Nicoline Hoogerbrugge, MD PhD

Role: CONTACT

Phone: +31-24-3613946

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Stan J Ketelaars, MD

Role: primary

Els JM Ahsmann, MD PhD

Role: primary

Jos Meijer, MD

Role: primary

Pieter J Westenend, MD PhD

Role: primary

Ineke van Lijnschoten, MD PhD

Role: primary

Sietske Riemersma, MD

Role: primary

Ton Tiebosch, MD PhD

Role: primary

Cilia M Ferrier, MD PhD

Role: primary

Joris J Grond, MD PhD

Role: primary

Erik Thunnissen, MD PhD

Role: primary

Sonja Henzen, MD PhD

Role: primary

Paul Blok, MD PhD

Role: primary

Anneke van der Wurff, MD PhD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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. doi: 10.1136/gut.2004.039123.

Reference Type BACKGROUND
PMID: 15591512 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16121665 (View on PubMed)

Overbeek LI, Hermens RP, van Krieken JH, Adang EM, Casparie M, Nagengast FM, Ligtenberg MJ, Hoogerbrugge N; MIPA study group. Electronic reminders for pathologists promote recognition of patients at risk for Lynch syndrome: cluster-randomised controlled trial. Virchows Arch. 2010 Jun;456(6):653-9. doi: 10.1007/s00428-010-0907-7. Epub 2010 Apr 9.

Reference Type DERIVED
PMID: 20379742 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ZonMw nr. 945-14-107

Identifier Type: -

Identifier Source: secondary_id

MIPA-2005

Identifier Type: -

Identifier Source: org_study_id