OBJECTIVE: Evidence-based counseling and prevention are not available so far for hereditary cancer prone persons, since we lack data based on clinical trials. There are very few high-risk persons in the population as a whole. Based on a familial history analysis, only 1.2% of all healthy volunteers attending screening centers reached the arbitrary high-risk level defined as a Relative Risk of more than 4. We describe a randomized trial based on colonoscopic screening for colorectal cancer on a sub-group of high-risk group persons. MATERIALS AND METHODS: Among the 77 members of the French Institutional Preventive Center Network, 37 took part in this protocol. During the first 3 years, 850,000 persons were interviewed at these 37 Health centers. The enrollment process was particularly time-consuming, since a large amount of information had to be delivered to the participants. RESULTS: The mean rate of recruitment of eligible candidates was far lower than predicted, averaging only 1.4 per 1,000 persons interviewed instead of the 9/1,000 expected. This mean figure was based, however, on inclusion rates ranging from 0.06/1,000 to 7/1,000 among the different centers. The low rates of recruitment were mainly due to the inter-center heterogeneity (differences in commitment and in the resources), and to the fact that the acceptability of undergoing a colonoscopy turned out to be lower than predicted. CONCLUSION: Population trials on cancer prone persons are feasible, but vast numbers have to be pre- screened to identify the few people with a high hereditary risk and willing to accept screening within a controlled trial.
RCT Entities:
OBJECTIVE: Evidence-based counseling and prevention are not available so far for hereditary cancer prone persons, since we lack data based on clinical trials. There are very few high-risk persons in the population as a whole. Based on a familial history analysis, only 1.2% of all healthy volunteers attending screening centers reached the arbitrary high-risk level defined as a Relative Risk of more than 4. We describe a randomized trial based on colonoscopic screening for colorectal cancer on a sub-group of high-risk group persons. MATERIALS AND METHODS: Among the 77 members of the French Institutional Preventive Center Network, 37 took part in this protocol. During the first 3 years, 850,000 persons were interviewed at these 37 Health centers. The enrollment process was particularly time-consuming, since a large amount of information had to be delivered to the participants. RESULTS: The mean rate of recruitment of eligible candidates was far lower than predicted, averaging only 1.4 per 1,000 persons interviewed instead of the 9/1,000 expected. This mean figure was based, however, on inclusion rates ranging from 0.06/1,000 to 7/1,000 among the different centers. The low rates of recruitment were mainly due to the inter-center heterogeneity (differences in commitment and in the resources), and to the fact that the acceptability of undergoing a colonoscopy turned out to be lower than predicted. CONCLUSION: Population trials on cancer prone persons are feasible, but vast numbers have to be pre- screened to identify the few people with a high hereditary risk and willing to accept screening within a controlled trial.
Authors: W Burke; G Petersen; P Lynch; J Botkin; M Daly; J Garber; M J Kahn; A McTiernan; K Offit; E Thomson; C Varricchio Journal: JAMA Date: 1997-03-19 Impact factor: 56.272
Authors: J D Hardcastle; J O Chamberlain; M H Robinson; S M Moss; S S Amar; T W Balfour; P D James; C M Mangham Journal: Lancet Date: 1996-11-30 Impact factor: 79.321
Authors: S J Winawer; A G Zauber; M N Ho; M J O'Brien; L S Gottlieb; S S Sternberg; J D Waye; M Schapiro; J H Bond; J F Panish Journal: N Engl J Med Date: 1993-12-30 Impact factor: 91.245
Authors: Usha Menon; Aleksandra Gentry-Maharaj; Andy Ryan; Aarti Sharma; Matthew Burnell; Rachel Hallett; Sara Lewis; Alberto Lopez; Keith Godfrey; David Oram; Jonathan Herod; Karin Williamson; Mourad Seif; Ian Scott; Tim Mould; Robert Woolas; John Murdoch; Stephen Dobbs; Nazar Amso; Simon Leeson; Derek Cruickshank; Ali McGuire; Stuart Campbell; Lesley Fallowfield; Steve Skates; Mahesh Parmar; Ian Jacobs Journal: BMJ Date: 2008-11-13
Authors: P Hopwood; D Wonderling; M Watson; A Cull; F Douglas; T Cole; D Eccles; J Gray; V Murday; M Steel; J Burn; K McPherson Journal: Br J Cancer Date: 2004-08-31 Impact factor: 7.640