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Screening for Colorectal Cancer With FOBT, Virtual Colonoscopy and Optical Colonoscopy. A Randomized Clinical Trial in the Florence District (SAVE)

This study is currently recruiting participants.
Verified March 2013 by Cancer Prevention and Research Institute, Italy
Sponsor:
Collaborator:
University of Florence
Information provided by (Responsible Party):
Cancer Prevention and Research Institute, Italy
ClinicalTrials.gov Identifier:
NCT01651624
First received: July 20, 2012
Last updated: March 21, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention
Colorectal Cancer
 Other: Invitation to screening

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Comparison Between Faecal Occult Blood Test (FOBT), Computed Tomographic Colonography (CTC) With Computer Aided Diagnosis (CAD) and Colonoscopy as a Primary Screening Test for Colorectal Cancer. Validation of a Teleradiology Model. Biological Banking in Subjects Recruited for Colonoscopy or CTC.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cancer Prevention and Research Institute, Italy:

Primary Outcome Measures:
  • Participation rate to faecal occult blood test (FOBT), computed tomographic colonography (CTC) and colonoscopy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Detection rate for cancer or advanced adenomas of CTC versus three rounds of FOBT every second year [ Time Frame: 6 years ] [ Designated as safety issue: No ]
  • Referral rate for colonoscopy induced by primary CTC versus three rounds of FOBT every second year [ Time Frame: 6 years ] [ Designated as safety issue: No ]
  • Costs of the three different screening strategies proposed [ Time Frame: 6 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Expected and perceived burden of colonoscopy and CTC [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Number and type of complications in all groups [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 14000
Study Start Date: December 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Computed tomographic colonography (CTC), reduced prep
Subjects invited to undergo CTC with reduced cathartic preparation
 Other: Invitation to screening
Experimental: Computed tomographic colonography (CTC), standard prep
Subjects invited to undergo CTC with standard bowel preparation
 Other: Invitation to screening
Active Comparator: Faecal occult blood test (FOBT)
Subjects invited to undergo FOBT
 Other: Invitation to screening
Experimental: Colonoscopy
Subjects invited to undergo colonoscopy
 Other: Invitation to screening

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   55 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Never invited to previous colorectal cancer screening.

Exclusion Criteria:

  • 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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01651624

Contacts
Contact: Grazia Grazzini, MD +3905532697972 g.grazzini@ispo.toscana.it
Contact: Lapo Sali, MD,PhD +390554377673 lapo.sali@unifi.it

Locations
Italy
Cancer Prevention and Research Institute, ISPO Recruiting
Firenze, FI, Italy, 50139
Sponsors and Collaborators
Cancer Prevention and Research Institute, Italy
University of Florence
Investigators
Principal Investigator: Stefano Milani, MD University of Florence
Study Director: Grazia Grazzini, MD Cancer Prevention and Research Institute, Italy
  More Information

No publications provided by Cancer Prevention and Research Institute, Italy

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Cancer Prevention and Research Institute, Italy
ClinicalTrials.gov Identifier: NCT01651624     History of Changes
Other Study ID Numbers: D65C09002710007, 432/10
Study First Received: July 20, 2012
Last Updated: March 21, 2013
Health Authority: Italy: National Institute of Health

Keywords provided by Cancer Prevention and Research Institute, Italy:
Colorectal Cancer
Screening
Fecal Occult Blood Test
 CT Colonography
Virtual Colonoscopy
Colonoscopy

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on June 18, 2013