|- candidate number||2818|
|- NTR Number||NTR1096|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||17-okt-2007|
|- Secondary IDs||63300022. ZonMW|
|- Public Title||Screening for colorectal cancer in the Netherlands;|
a study comparing attendance and feasibility of two different forms of
faecal occult blood testing and sigmoidoscopy.
|- Scientific Title||Screening for colorectal cancer in the Netherlands;|
a study comparing attendance and feasibility of two different forms of faecal occult blood testing and sigmoidoscopy.
|- hypothesis||To determine attendance for CRC screening with guaiac based FOBT (Haemoccult II), immunochemical FOBT (OC-Hemodia Latex) and sigmoidoscopy.|
|- Healt Condition(s) or Problem(s) studied||Colorectal cancer|
|- Inclusion criteria||1. 50-75 year old;|
2. Ability to provide informed consent.
|- Exclusion criteria||1. Inability or refusal to provide informed consent;|
2. History of colorectal cancer, adenomas, inflammatory bowel disease*;
3. Severe or terminal disease, life expectancy less than five years;
4. Colonoscopy, sigmoidoscopy or contrast barium enema within the previous three years.
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-nov-2006|
|- planned closingdate||1-apr-2008|
|- Target number of participants||15000|
|- Interventions||1. Sigmoidoscopy;|
2. Guaiac fecal occult bloed test;
3. Immunochemical fecal occult bloed test.
|- Primary outcome||Attendance for CRC screening with guaiac based FOBT (Haemoccult II), immunochemical FOBT (OC-Hemodia Latex) and sigmoidoscopy.|
|- Secondary outcome||1. The diagnostic yield of FOBT screening and sigmoidoscopy based screening in the Netherlands;|
2. The feasibility and required capacity for primary sigmoidoscopy CRC screening in our country;
3. The feasibility and required colonoscopy capacity needed for further evaluation of participants with a positive screening test in relation to the initial screening method used;
4. Side effects of screening;
5. Participants experiences; the acceptability, satisfaction and burden of screening (FOBT or sigmoidoscopy);
6. Identification of optimal choices for implementation of a CRC screening program (process evaluation);
7. Comparison of the cost-effectiveness ratio of the two forms of FOBT and sigmoidoscopy in CRC screening.
|- Timepoints||Start: 1-11-07|
Interim analysis: none
|- Trial web site||www.dikkedarmkankerpreventie.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD L. Hol|
|- CONTACT for SCIENTIFIC QUERIES||Prof. dr. E.J. Kuipers|
|- Sponsor/Initiator ||Erasmus Medical Center, Department of Gastroenterology and Hepatology|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development, KWF Kankerbestrijding|
|- Publications||Manuscript in progress.
|- Brief summary||Colorectal cancer (CRC) is a major health problem and the second most common cause of death from cancer in the Netherlands. Screening can detect precursor lesions and early cancers, which reduces
CRC incidence and mortality. For this reason, introduction of a CRC screening program in the Netherlands is being explored. The benefits of screening depend on the efficacy and costs of the screening method as well as on population attendance. The currently most relevant screening methods for the Netherlands are faecal occult blood testing (FOBT) and sigmoidoscopy, with the latter being more expensive but also with potentially higher preventive impact. The Health Council and the national colorectal carcinoma screening investigation group (CoCast) therefore recommended to study implementation aspects of screening by FOBT, and to directly compare FOBT and sigmoidoscopy screening. In accordance with the first recommendation, an FOBT implementation trial is due to start in Amsterdam and Nijmegen. In accordance with the second recommendation, we propose a randomised trial comparing FOBT with sigmoidoscopy screening for CRC. This is in line with the Dutch ZonMw / KWF consensus development meeting for implementation and further development of population screening for CRC, which advised further research in endoscopic procedures. A representative sample of the Dutch population, consisting of 15,000 asymptomatic persons between 50 and 74 years of age will be pre-randomised and invited to perform a guaiac based FOBT (Haemoccult II; group A), an immunochemical FOBT (OC-Hemodia Latex; group B), or to undergo sigmoidoscopy (group C). Individuals with a history of CRC or polyps, a strong family history for CRC, inflammatory bowel disease or major health problems will be excluded from the screening program. Persons in group A and B will receive an FOBT set by mail. In group A the participant will be asked to place three faeces samples from three bowel movements on a card and returns it by mail to the laboratory. In group B one faeces sample will be collected into a special tube and returned by mail to the
laboratory. Persons in group C will be invited for sigmoidoscopy in the screening centre. Persons with a positive FOBT (indicative for blood in the stool) or with a positive sigmoidoscopy (polyps meeting high-risk criteria or CRC in the rectosigmoid or colon descendens) will be referred for colonoscopy. Polyps will be removed during colonoscopy and in case of CRC, the patient will be referred to the hospital for further treatment. Every two months a steering committee will evaluate all of the results. |
The organization will be done by the ‘Stichting Bevolkingsonderzoek Borstkanker Zuidwest Nederland’ together with the department of Gastroenterology and Hepatology and the department of Public Health of the Erasmus MC.
This study will yield differential data on attendance, implementation aspects, diagnostic yield, personnel demands, acceptability and costs, including costs of sigmoidoscopy when performed in a high
through-put screening centre. This study will evaluate two forms of FOBT in accordance with the Dutch FOBT implementation trial. As it is unknown which of the two FOBTs will be preferred based on that trial, we will compare both to sigmoidoscopy. Moreover, this will give additional information for the
comparison between the two FOB-tests, with a replication in a different setting than in the Dutch FOBT implementation trial. We will incorporate the results of both implementation trials in a cost-effectiveness
analysis of FOBT and sigmoidoscopy screening in the Netherlands Randomized controlled trials on the extent and duration of the incidence and mortality reduction with sigmoidoscopy are presently also being carried out in the UK, Italy and the USA. Together with the results of these studies, our results will form the basis of decision making for implementing a colorectal cancer screening program in the Netherlands. The proposed study will reveal results in the same time frame as the effectiveness trials in the UK and Italy, and the combined data will enable the comparative cost-effectiveness analysis. It is essential that the pro-active data collection proposed in this study begins on time so that all the data are available without delay for the decision making process for a national colorectal cancer screening program within several years.
|- Main changes (audit trail)|
|- RECORD||17-okt-2007 - 20-mrt-2008|