Ignite Creation Date:
2024-05-06 @ 12:46 AM
Last Modification Date:
2024-10-26 @ 10:54 AM
Study NCT ID:
NCT01651624
Status:
COMPLETED
Last Update Posted:
2018-11-27
First Post:
2012-07-20
Brief Title:
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
Organization:
Cancer Prevention and Research Institute Italy
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAVE
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
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
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
14000 subjects aged 55-64 years living in the Florence District and never screened for colorectal cancer will be randomized in 3 arms
group 1 5000 persons invited to CTC divided into subgroup 1A with reduced cathartic preparation and subgroup 1B with standard bowel preparation
group 2 8000 persons invited to biannual FOBT for 3 rounds
group 3 1000 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 ngml 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
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
14000 subjects aged 55-64 years living in the Florence District and never screened for colorectal cancer will be randomized in 3 arms
group 1 5000 persons invited to CTC divided into subgroup 1A with reduced cathartic preparation and subgroup 1B with standard bowel preparation
group 2 8000 persons invited to biannual FOBT for 3 rounds
group 3 1000 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 ngml 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 43210 | OTHER | Local Ethics Committee of Local Health Unit of Florence | None |