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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 ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01651624
First Posted: July 27, 2012
Last Update Posted: August 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Florence
Information provided by (Responsible Party):
Cancer Prevention and Research Institute, Italy
  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: None (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:


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 ]
  • Detection rate for cancer or advanced adenomas of CTC versus three rounds of FOBT every second year [ Time Frame: 6 years ]
  • Referral rate for colonoscopy induced by primary CTC versus three rounds of FOBT every second year [ Time Frame: 6 years ]
  • Costs of the three different screening strategies proposed [ Time Frame: 6 years ]

Secondary Outcome Measures:
  • Expected and perceived burden of colonoscopy and CTC [ Time Frame: 2 years ]
  • Number and type of complications in all groups [ Time Frame: 2 years ]

Estimated Enrollment: 14000
Study Start Date: December 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01651624


Locations
Italy
Cancer Prevention and Research Institute, ISPO
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

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 ( Other Identifier: Local Ethics Committee of Local Health Unit of Florence )
First Submitted: July 20, 2012
First Posted: July 27, 2012
Last Update Posted: August 1, 2017
Last Verified: July 2017

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


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