Assessment of the Participation Rate and the Diagnostic Accuracy of a Colorectal Cancer Screening Program: CT Colonography Versus Flexible Sigmoidoscopy. Evaluation of a New Model Based on Telediagnosis
Design:
- To compare detection of advanced neoplasia of CT colonography (CTC) to sigmoidoscopy
(FS), a total of 20.000 eligible individuals living in the target areas are mailed an
invitation letter to participate in the trial. All invitees are asked to call the
screening centre in order to receive detailed information about study protocol, the
screening examinations and the bowel preparation. Responders who consent to participate
in the study are randomly assigned to undergo screening with CTC or FS. All
non-responders will be invited to Fecal Occult Blood test (FOBT) according to the
current screening procedure. In the CTC arm, positive patients (containing at least one
polyp 6 mm or larger) are referred to colonoscopy; negative patients (no polyps >5 mm)
are scheduled to be invited to have an FOBT after two years. In the FS arm, positive
patients (at least one advanced adenoma found during FS examination) are referred to
colonoscopy; negative patients are offered no further follow-up.
- To compare participation rate to FS and CTC, 1200 individuals living in the target
areas and never screened for colorectal cancer, are randomly assigned to receive an
invitation for screening with CTC or FS. Individuals of both groups will receive an
invitation letter and an information leaflet, containing information about colorectal
cancer, importance of screening, and advantages and possible risks of the selected
test. Invitation letter for CTC contains a phone number of the screening centre. All
invitees are asked to call the screening centre in order to receive information about
bowel preparation. All non-responders will receive a remainder by mail after one month.
Non-responders to reminder will be invited to FS according with current screening
procedure. In the CTC arm, positive patients (containing at least one polyp 6 mm or
larger) are referred to colonoscopy; negative patients (no polyps >5 mm) are scheduled
to be invited to have an FOBT after two years. In the FS arm, positive patients (at
least one advanced adenoma found during FS examination) are referred to colonoscopy;
negative patients are offered no further follow-up.
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening
Detection rate for cancer and advanced adenoma of CT Colonography versus FS in an invitational CRC screening program
three years
No
Daniele Regge, MD
Principal Investigator
Institute for Cancer Research and Treatment at Candiolo
Italy: National Institute of Health
14334-c27.2
NCT01739608
December 2010
December 2015
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