Comparative analysis of the protective effect of different screening strategies for colorectal cancer

Not Applicable

Completed

• Conditions: Colorectal cancer; Cancer

• Registration Number: ISRCTN81517281
• Lead Sponsor: AIRC Scientific Directorate

Brief Summary

2005 Results article in https://pubmed.ncbi.nlm.nih.gov/15741571/ Results of the recruitment phase of the trial referring to the first phase of the study, which involved all centers. The data from the extended enrolment in Turin were not available yet for this analysis. (added 14/08/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-12-31
• Study Start: 2023-10-19
• Last Update Posted: 30 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30180

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
All-cause mortality measured using an automated record linkage of the trial database and the local population mortality registries at 15-year follow-up<br><br>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).<br>