ORLANDOPersons genetically at risk for colon cancer
appear enthusiastic about participating in prevention trials, but
researchers at Johns Hopkins had to recruit a large number of
potential participants over a span of 2 years to find 41 people who
qualified for their study and were willing to enroll, Linda Hylind,
RN, said at Digestive Disease Week.
Starting in 1993, the Johns Hopkins researchers contacted 426 people
in 37 states who were related to patients in the Hopkins familial
adenomatous polyposis (FAP) registry. Of these 426 individuals, 201
(47%) said they were willing to join the study
(acceptors), and 41 (10% of the initial group of 426)
qualified for and ultimately enrolled in the study. To qualify, the
person had to have both the adenomatous polyposis coli (APC) gene and
a colon free of polyps.
The acceptors are highly motivated, Ms. Hylind said.
Often they have watched a relative in his 30s or 40s die of
colon cancer. The process of recruitment took about 2 years, and it
involved many long telephone conversations. The researchers
engaged in a mean of 4.7 phone conversations with acceptors before
enrollment and a mean of 6.1 phone calls with nonacceptors.
The distance between the research center and the persons home
did not prove a significant barrier. Acceptors lived an average 423
miles away, while nonac-ceptors lived 437 miles away. Race did prove
a significant factor in study participation. Family members from 2 of
10 (20%) black families in the registry accepted participation vs 80
of 126 (63%) white families (P < .05).
The randomized, controlled, double-blind study offers genetic
screening and sigmoidoscopy to all participants and randomization to
an NSAID (sulindac) or placebo. Every 4 months, the researchers
perform flexible sigmoidoscopy and draw blood for testing.
If polyps develop and become too large or too numerous, the
participant is removed from the study and is referred to his or her
local gastroenterologist for recommendations and continued management
of the disease, or for consultation for surgery. We will
complete and publish this research within about a year, Ms.