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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. (see Contacts and Locations)
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
  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:


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

  Hide Detailed Description

Detailed Description:

OBJECTIVES:

Primary objectives:

  • To compare the participation rate to faecal occult blood test (FOBT), computed tomographic colonography (CTC) and colonoscopy (CO) as a primary screening test in a population-based programme for colorectal cancer.
  • To compare the participation rate to CTC with reduced cathartic preparation versus CTC with standard bowel preparation.
  • To compare the detection rate for cancer or advanced adenomas of CTC with computer aided diagnosis (CAD) versus three rounds of FOBT every second year.
  • To evaluate referral rate for colonoscopy induced by primary CTC versus three rounds of FOBT every second year.
  • To compare costs of the three screening strategies.

Secondary objectives:

  • To compare the expected and perceived discomfort of colonoscopy and computed tomographic colonography as assessed with a structured questionnaire.
  • To evaluate the rate of complications in each group.
  • To validate a teleradiology model for computed tomographic colonography.
  • To create a biological bank of blood and stool specimens from subjects who undergo computed tomographic colonography, primary colonoscopy and second level colonoscopy.

DESIGN:

14,000 subjects aged 55-64 years, living in the Florence District and never screened for colorectal cancer, will be randomized in 3 arms:

  • group 1 (5,000 persons) invited to CTC (divided into: subgroup 1A with reduced cathartic preparation and subgroup 1B with standard bowel preparation);
  • group 2 (8,000 persons) invited to biannual FOBT for 3 rounds;
  • group 3 (1,000 persons) invited to CO.

Subjects of each group will be invited by mail to undergo the selected test. Individuals of each group will receive an invitation letter and an information leaflet, containing information about colorectal cancer, importance of screening, and advantages and possible risks of the selected test.

Invitation letter for the FOBT group contains instructions on how to pick-up the kit test at the nearest pharmacy. The FOBT screening test adopted is OC-SENSOR DIANA (Eiken Chemical Co., Tokyo, Japan), a quantitative, completely automated immunochemical test, based on latex agglutination. Positivity threshold is set at 100 ng/ml of sample solution. Invited subjects are asked to collect a single sample of faeces, without dietary restrictions. Sample are retuned according to the routine procedure of Florence screening programme.

Invitation letter for CTC and colonoscopy contains a phone number and an email address of the screening centre. All invitees have the option to call or send an email to the screening centre in order to receive an appointment for a prior consultation. All non-responders will receive a remainder by mail after three months. Non-responders to reminder will be invited to FOBT according with current screening procedure.

Subjects who accept invitation for CTC or CO will have a consultation at the screening centre with a trained nurse. During the consultation subjects will be informed about the study protocol, the screening examination to which they are invited, the bowel preparation, and the management in case of positive results. All subjects tested positive to FOBT or CTC (mass or at least one polyp ≥ 6 mm) will be invited to undergo total colonoscopy. Then, subjects will be scheduled for the selected examination (CTC or CO).

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on November 27, 2014