Participation and Detection Rate of Screening CT Colonography and Screening Sigmoidoscopy
NCT01739608 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40945
Last updated 2020-01-31
Summary
The objectives of this multicenter, randomized trial is to assess the participation rate achievable through two different screening strategies (Computed Tomographic Colonography-CTC and sigmoidoscopy-FS), to compare detection rate of colorectal cancer (CRC) and advanced adenoma of tests and to evaluate their costs. The role of Computer-aided detection (CAD) for CTC screening will be also assessed. The trial involves 10 Italian centers located in the Piedmont Region and in Verona. Residents aged 58-60 years in those districts are target for recruitment. Exclusion criteria include: previous diagnosis of cancer or adenoma; family history or hereditary syndromes; personal history of inflammatory bowel disease; patients screened by colonoscopy or FOBT within 2 years; severe disease.
Conditions
Interventions
- OTHER
-
Invitation to screening
Invitation to screening
Sponsors & Collaborators
-
im3D S.p.A.
collaborator OTHER -
Regione Piemonte
collaborator OTHER -
Candiolo Cancer Institute - IRCCS
collaborator OTHER -
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
lead OTHER
Principal Investigators
-
Daniele Regge, MD · Institute for Cancer Research and Treatment at Candiolo
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SCREENING
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 58 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-12-31
- Primary Completion
- 2014-12-31
- Completion
- 2018-12-31
Countries
- Italy
Study Locations
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