Ignite Creation Date:
2025-12-24 @ 4:24 PM
Ignite Modification Date:
2026-01-05 @ 5:16 PM
Study NCT ID:
NCT00141466
Status:
UNKNOWN
Last Update Posted:
2008-04-23
First Post:
2005-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implementation of a New Strategy to Identify HNPCC Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D003123', 'term': 'Colorectal Neoplasms, Hereditary Nonpolyposis'}, {'id': 'D053842', 'term': 'Microsatellite Instability'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D049914', 'term': 'DNA Repair-Deficiency Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D042822', 'term': 'Genomic Instability'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 360}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-02', 'completionDateStruct': {'date': '2007-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-04-22', 'studyFirstSubmitDate': '2005-08-31', 'studyFirstSubmitQcDate': '2005-08-31', 'lastUpdatePostDateStruct': {'date': '2008-04-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of inclusion of eligible CRC-patients for MSI testing by pathologists.'}, {'measure': 'Efficacy of referral of patients who are MSI positive to a clinical geneticist by surgeons.'}], 'secondaryOutcomes': [{'measure': 'Experiences with and acceptance of changed physician practice roles by patients and clinicians.'}, {'measure': 'Cost efficacy of the implementation procedures.'}]}, 'conditionsModule': {'keywords': ['Hereditary colorectal cancer', 'Microsatellite instability', 'Physician roles', 'Health care implementation', 'Intervention'], 'conditions': ['Colorectal Neoplasms', 'Hereditary Nonpolyposis Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '15591512', 'type': 'BACKGROUND', '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. doi: 10.1136/gut.2004.039123.'}, {'pmid': '16121665', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20379742', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Colorectal cancer before the age of 50 years\n* Second colorectal cancer at any age\n* Colorectal cancer and other HNPCC associated extracolonic cancer irrespective of age at diagnosis\n* Adenoma with high grade dysplasia diagnosed before the age of 40 years'}, 'identificationModule': {'nctId': 'NCT00141466', 'briefTitle': 'Implementation of a New Strategy to Identify HNPCC Patients', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'Cost Effectiveness of Two Different Implementation Procedures to Change Clinicians Practice Roles in the Detection of Hereditary Colorectal Cancer', 'orgStudyIdInfo': {'id': 'MIPA-2005'}, 'secondaryIdInfos': [{'id': 'ZonMw nr. 945-14-107'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Education for professionals', 'type': 'BEHAVIORAL'}, {'name': 'Distribution of educational materials', 'type': 'BEHAVIORAL'}, {'name': 'Feedback for professionals', 'type': 'BEHAVIORAL'}, {'name': 'Reminders for professionals', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'city': "'s-Hertogenbosch", 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Stan J Ketelaars, MD', 'role': 'CONTACT'}], 'facility': 'Jeroen Bosch Ziekenhuis', 'geoPoint': {'lat': 51.69917, 'lon': 5.30417}}, {'city': 'Amersfoort', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Els JM Ahsmann, MD PhD', 'role': 'CONTACT'}], 'facility': 'Meander Medisch Centrum', 'geoPoint': {'lat': 52.155, 'lon': 5.3875}}, {'city': 'Arnhem', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Jos Meijer, MD', 'role': 'CONTACT'}], 'facility': 'Ziekenhuis Rijnstate', 'geoPoint': {'lat': 51.98, 'lon': 5.91111}}, {'city': 'Dordrecht', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Pieter J Westenend, MD PhD', 'role': 'CONTACT'}], 'facility': 'Pathologie laboratorium voor Dordrecht', 'geoPoint': {'lat': 51.81, 'lon': 4.67361}}, {'city': 'Eindhoven', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Ineke van Lijnschoten, MD PhD', 'role': 'CONTACT'}], 'facility': 'Stichting laboratoria voor pathologische anatomie en medische microbiologie', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'city': 'Enschede', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Sietske Riemersma, MD', 'role': 'CONTACT'}], 'facility': 'Laboratorium voor pathologie Oost-Nederland', 'geoPoint': {'lat': 52.21833, 'lon': 6.89583}}, {'city': 'Groningen', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Ton Tiebosch, MD PhD', 'role': 'CONTACT'}], 'facility': 'Martini Ziekenhuis', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'city': 'Helmond', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Cilia M Ferrier, MD PhD', 'role': 'CONTACT'}], 'facility': 'Elkerliek Ziekenhuis', 'geoPoint': {'lat': 51.48167, 'lon': 5.66111}}, {'city': 'Leeuwarden', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Joris J Grond, MD PhD', 'role': 'CONTACT'}], 'facility': 'Laboratorium Volksgezondheid Friesland', 'geoPoint': {'lat': 53.20271, 'lon': 5.80973}}, {'city': 'Nijmegen', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Erik Thunnissen, MD PhD', 'role': 'CONTACT'}], 'facility': 'Canisius Wilhelmina Ziekenhuis', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'city': 'Rotterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Sonja Henzen, MD PhD', 'role': 'CONTACT'}], 'facility': 'Medisch Centrum Rijnmond Zuid', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'The Hague', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Paul Blok, MD PhD', 'role': 'CONTACT'}], 'facility': 'HagaZiekenhuis', 'geoPoint': {'lat': 52.07667, 'lon': 4.29861}}, {'city': 'Tilburg', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Anneke van der Wurff, MD PhD', 'role': 'CONTACT'}], 'facility': 'St. Elisabeth Ziekenhuis', 'geoPoint': {'lat': 51.55551, 'lon': 5.0913}}], 'centralContacts': [{'name': 'Lucy I Overbeek, MSc', 'role': 'CONTACT', 'email': 'l.overbeek@antrg.umcn.nl', 'phone': '+31-24-3613946'}, {'name': 'Nicoline Hoogerbrugge, MD PhD', 'role': 'CONTACT', 'email': 'n.hoogerbrugge@antrg.umcn.nl', 'phone': '+31-24-3613946'}], 'overallOfficials': [{'name': 'Nicoline Hoogerbrugge, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Human Genetics, Radboud University Nijmegen Medical Center'}, {'name': 'Rosella P Hermens, MSc PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center of Quality of Care Research, Radboud University Nijmegen Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'ZonMw: The Netherlands Organisation for Health Research and Development', 'class': 'OTHER'}]}}}