Cancer prone persons. A randomized screening trial based on colonoscopy: background, design and recruitment.
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.


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.


CONCLUSIONS
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.
Institute Paoli-Calmettes, 232 Bd., St. Marguerite, 13009 Marseille, France. eisinger@marseile.inserm.fr
F
F
Eisinger
J P
JP
Giordanella
A
A
Brigand
R
R
Didelot
D
D
Jacques
G
G
Schenowitz
C
C
Julian-Reynier
J F
JF
Seitz
H
H
Sobol
J
J
Faivre
H
H
Allemand
D000293:Adolescent; D000328:Adult; D000368:Aged; D003113:Colonoscopy; D015179:Colorectal Neoplasms / Q000175:diagnosis* / Q000453:epidemiology / Q000235:genetics*; D015340:Epidemiologic Research Design; D005260:Female; D005602:France / Q000453:epidemiology; D020022:Genetic Predisposition to Disease; D006801:Humans; D015994:Incidence; D008297:Male; D008403:Mass Screening; D008875:Middle Aged; D018579:Patient Selection; D012307:Risk Factors