Colorectal cancer Cancer
Conditions
Interventions
Eligible subjects were randomized in the trial through a computer-generated random sequence (Randomized blocks sequence) within general practitioner (GP).
During the initial phase involving all cente
kit sent by mail with the invitation
2. Biennial faecal immunochemical test (FIT)
kit delivered at the pharmacies of by GPs
3. Patient’s choice of FIT or “once-only ” sigmoidoscopy
4. “Once-only” sigmoidoscopy
5. Sigmoidoscopy followed by biennial FIT for subjects with negative scr
kit delivered at the pharmacies of by GPs
3. Patient’s choice of FIT or “once-only ” sigmoidoscopy
4. "Once-only” sigmoidoscopy
5. Sigmoidoscopy followed by biennial FIT for subjects with negative scr
Sponsors
AIRC Scientific Directorate
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In Turin and Milan, the target population included all patients aged 55 – 64 years who were listed in the rosters of a random sample of general practitioners who had not been involved in a previous trial (SCORE ISRCTN27814061 of 08/12/2010). In the other centers, the target population was recruited from those districts not yet involved in the SCORE trial (Biella and Rimini) or in the ongoing regional colorectal cancer screening program (Florence). All residents aged 55 – 64 years in those districts were targeted for recruitment: the researchers identified and contacted their general practitioners, who were invited to collaborate in the study. In all centers, GPs were asked to review the list of their patients targeted for recruitment to exclude subjects not eligible for the trial.
Exclusion criteria
Exclusion criteria: 1. Unable to give informed consent 2. Diagnosed with a terminal illness or inflammatory bowel disease 3. History of polyps or colorectal cancer or two first-degree relatives with colorectal cancer 4. Undergone a colorectal endoscopy or a FOBT within the previous 2 years 5. Already included in a previous trial (SCORE ISRCTN27814061 - 08/12/2010) and had changed their general practitioner to one that was included in this study or who had moved to a district included in the current study area
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Colorectal cancer (CRC) incidence and mortality measured using a record linkage of the trial database with local population cancer and mortality registers at 15-year follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| All-cause mortality measured using an automated record linkage of the trial database and the local population mortality registries at 15-year follow-up The study aims also to study the screening outcomes with different strategies. The outcome indicators include participation, positivity rate, positive predictive value, DR of CRC and advanced adenomas. Cumulative estimates are used to compare strategies based on the offer of a single test over the lifetime (FS and TC) and those requiring regular repetition of the test (FIT). | — |
Countries
Italy
Outcome results
None listed