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

Sponsor

Cancer Prevention and Research Institute, Italy (Other)

Overall Status

Completed

CT.gov ID

NCT01651624

Collaborator

University of Florence (Other)

16,087

Enrollment

Location

Arms

71.8

Duration (Months)

224.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Other: Invitation to screening	N/A

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

16087 participants

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.

Study Start Date :

Dec 1, 2012

Actual Primary Completion Date :

Nov 25, 2018

Actual Study Completion Date :

Nov 25, 2018

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Expected and perceived burden of colonoscopy and CTC [2 years]
Number and type of complications in all groups [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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