Clinical trial · Interventional
Participation and Detection Rate of Screening CT Colonography and Screening Sigmoidoscopy
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Invitation to screening | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CT Colonography (CTC)
- description
- Invitation to screening. Subject who consent to participate in the study undergo to low dose CTC examination with limited bowel preparation.
- interventionNames
- Other: Invitation to screening
- type
- ACTIVE_COMPARATOR
- label
- Sigmoidoscopy (FS)
- description
- Invitation to screening. Subjects who consent to participate in the study undergo to FS.
- interventionNames
- Other: Invitation to screening
Primary outcomes (2)
- measure
- Detection rate for cancer and advanced adenoma of CT Colonography versus FS in an invitational CRC screening program
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 58 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Asymptomatic individuals, at average risk for CRC, 58-60 years old. Exclusion Criteria: * Personal history of CRC or polyps * Family history of CRC or polyps * A terminal illness or inflammatory bowel disease * Previous five years complete colonoscopy or a FOBT within the previous 2 years * Patients who are unable to give informed consent
References
Publications (2)
- DERIVEDRegge D, Iussich G, Segnan N, Correale L, Hassan C, Arrigoni A, Asnaghi R, Bestagini P, Bulighin G, Cassinis MC, Ederle A, Ferraris A, Galatola G, Gallo T, Gandini G, Garretti L, Martina MC, Molinar D, Montemezzi S, Morra L, Motton M, Occhipinti P, Pinali L, Soardi GA, Senore C. Comparing CT colonography and flexible sigmoidoscopy: a randomised trial within a population-based screening programme. Gut. 2017 Aug;66(8):1434-1440. doi: 10.1136/gutjnl-2015-311278. Epub 2016 Apr 12. PMID 27196588
- DERIVEDRegge D, Iussich G, Senore C, Correale L, Hassan C, Bert A, Montemezzi S, Segnan N. Population screening for colorectal cancer by flexible sigmoidoscopy or CT colonography: study protocol for a multicenter randomized trial. Trials. 2014 Mar 28;15:97. doi: 10.1186/1745-6215-15-97. PMID 24678896