NCT01651624

Brief Summary

RATIONALE: Computed tomographic colonography (CTC) has proven to be accurate in detecting colorectal neoplasms and may be a primary test in colorectal cancer screening. PURPOSE: This clinical trial will compare participation rate, diagnostic yield and costs of computed tomographic colonography, faecal occult blood test (FOBT) and colonoscopy (CO) as a primary screening test in a population-based programme.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16,087

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
Completed

Started Dec 2012

Longer than P75 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 27, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2018

Completed
Last Updated

November 27, 2018

Status Verified

November 1, 2018

Enrollment Period

6 years

First QC Date

July 20, 2012

Last Update Submit

November 25, 2018

Conditions

Colorectal Cancer

Keywords

Colorectal CancerScreeningFecal Occult Blood TestCT ColonographyVirtual ColonoscopyColonoscopy

Outcome Measures

Primary Outcomes (4)

  • Participation rate to faecal occult blood test (FOBT), computed tomographic colonography (CTC) and colonoscopy

    2 years

  • Detection rate for cancer or advanced adenomas of CTC versus three rounds of FOBT every second year

    6 years

  • Referral rate for colonoscopy induced by primary CTC versus three rounds of FOBT every second year

    6 years

  • Costs of the three different screening strategies proposed

    6 years

Secondary Outcomes (2)

  • Expected and perceived burden of colonoscopy and CTC

    2 years

  • Number and type of complications in all groups

    2 years

Study Arms (4)

Computed tomographic colonography (CTC), reduced prep

EXPERIMENTAL

Subjects invited to undergo CTC with reduced cathartic preparation

Other: Invitation to screening

Computed tomographic colonography (CTC), standard prep

EXPERIMENTAL

Subjects invited to undergo CTC with standard bowel preparation

Other: Invitation to screening

Faecal occult blood test (FOBT)

ACTIVE COMPARATOR

Subjects invited to undergo FOBT

Other: Invitation to screening

Colonoscopy

EXPERIMENTAL

Subjects invited to undergo colonoscopy

Other: Invitation to screening

Interventions

Invitation to screeningOTHER
ColonoscopyComputed tomographic colonography (CTC), reduced prepComputed tomographic colonography (CTC), standard prepFaecal occult blood test (FOBT)

Eligibility Criteria

Age55 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Never invited to previous colorectal cancer screening.

You may not qualify if:

  • Personal history of colorectal cancer or colonic advanced adenomas.
  • Inflammatory bowel disease (IBD).
  • Previous five years complete colonoscopy or previous two years faecal occult blood test (FOBT).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Prevention and Research Institute, ISPO

Florence, FI, 50139, Italy

Location

Related Publications (2)

  • Sali L, Ventura L, Mascalchi M, Falchini M, Mallardi B, Carozzi F, Milani S, Zappa M, Grazzini G, Mantellini P. Single CT colonography versus three rounds of faecal immunochemical test for population-based screening of colorectal cancer (SAVE): a randomised controlled trial. Lancet Gastroenterol Hepatol. 2022 Nov;7(11):1016-1023. doi: 10.1016/S2468-1253(22)00269-2. Epub 2022 Sep 16.

    PMID: 36116454DERIVED

  • Sali L, Grazzini G, Carozzi F, Castiglione G, Falchini M, Mallardi B, Mantellini P, Ventura L, Regge D, Zappa M, Mascalchi M, Milani S. Screening for colorectal cancer with FOBT, virtual colonoscopy and optical colonoscopy: study protocol for a randomized controlled trial in the Florence district (SAVE study). Trials. 2013 Mar 15;14:74. doi: 10.1186/1745-6215-14-74.

    PMID: 23497601DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Stefano Milani, MD

    University of Florence

    PRINCIPAL INVESTIGATOR

  • Grazia Grazzini, MD

    Cancer Prevention and Research Institute, Italy

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2012

First Posted

July 27, 2012

Study Start

December 1, 2012

Primary Completion

November 25, 2018

Study Completion

November 25, 2018

Last Updated

November 27, 2018

Record last verified: 2018-11

Locations

IT(1)