Colorectal CancerSAVENCT01651624
Screening for Colorectal Cancer With FOBT, Virtual Colonoscopy and Optical Colonoscopy. A Randomized Clinical Trial in the Florence District
A study testing Invitation to screening in people with Colorectal Cancer, run by Cancer Prevention and Research Institute, Italy at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Invitation to screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16,087 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2012to 25 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Never invited to previous colorectal cancer screening.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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).
- Conditions
- Colorectal Cancer
- Being tested
- Invitation to screening
- Keywords
- Colorectal Cancer, Screening, Fecal Occult Blood Test, CT Colonography, Virtual Colonoscopy, Colonoscopy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invitation to screeningOther
| Study group | Role | What they receive |
|---|---|---|
| Computed tomographic colonography (CTC), reduced prep | Experimental | Subjects invited to undergo CTC with reduced cathartic preparation Receives: Other: Invitation to screening |
| Computed tomographic colonography (CTC), standard prep | Experimental | Subjects invited to undergo CTC with standard bowel preparation Receives: Other: Invitation to screening |
| Faecal occult blood test (FOBT) | Active comparator | Subjects invited to undergo FOBT Receives: Other: Invitation to screening |
| Colonoscopy | Experimental | Subjects invited to undergo colonoscopy Receives: Other: Invitation to screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation rate to faecal occult blood test (FOBT), computed tomographic colonography (CTC) and colonoscopy
Measured: 2 years
Detection rate for cancer or advanced adenomas of CTC versus three rounds of FOBT every second year
Measured: 6 years
Referral rate for colonoscopy induced by primary CTC versus three rounds of FOBT every second year
Measured: 6 years
Costs of the three different screening strategies proposed
Measured: 6 years
Secondary outcomes (2)
Expected and perceived burden of colonoscopy and CTC
Measured: 2 years
Number and type of complications in all groups
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2012 (estimated)
- Study startDec 2012
- Primary completion25 Nov 2018
- Study completion25 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16,087 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Prevention and Research Institute, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- University of Florence
- Responsible party
- Sponsor
- Investigators
- Stefano Milani, MD, Principal investigator, University of FlorenceGrazia Grazzini, MD, Study director, Cancer Prevention and Research Institute, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01651624
- Sponsor's protocol ID
- D65C09002710007
- Other IDs
- 432/10
- Acronym
- SAVE
- Status last verified
- Nov 2018
- First submitted
- 20 Jul 2012
- Last updated
- 27 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Puliti D, Sali L, Mascalchi M, Manneschi G, Intrieri T, Caldarella A, Mallardi B, Masala G, Gorini G, Zappa M, Mantellini P. Colorectal Cancer and Advanced Adenoma after Single CT Colonography or Biennial FIT Screening in the SAVE Randomized Controlled Trial. Radiology. 2025 Sep;316(3):e250091. doi: 10.1148/radiol.250091.
PubMed 41025989Sali L, Ventura L, Mascalchi M, Falchini M, Mallardi B, Carozzi F, Milani S, Zappa M, Grazzini G, Mantellini P. Single CT colonography versus three rounds of faecal immunochemical test for population-based screening of colorectal cancer (SAVE): a randomised controlled trial. Lancet Gastroenterol Hepatol. 2022 Nov;7(11):1016-1023. doi: 10.1016/S2468-1253(22)00269-2. Epub 2022 Sep 16.
PubMed 36116454Sali L, Grazzini G, Carozzi F, Castiglione G, Falchini M, Mallardi B, Mantellini P, Ventura L, Regge D, Zappa M, Mascalchi M, Milani S. Screening for colorectal cancer with FOBT, virtual colonoscopy and optical colonoscopy: study protocol for a randomized controlled trial in the Florence district (SAVE study). Trials. 2013 Mar 15;14:74. doi: 10.1186/1745-6215-14-74.
PubMed 23497601
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01651624
- Acronym / sponsor ID
- SAVE / D65C09002710007
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Cancer, Screening, Fecal Occult Blood Test, CT Colonography, Virtual Colonoscopy, Colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16,087 participants (actual)
- Lead sponsor
- Cancer Prevention and Research Institute, ItalyUniversity, hospital or other
- Collaborators
- University of Florence
- Study start
- Dec 2012
- Primary completion
- 25 Nov 2018 (actual)
- Study completion
- 25 Nov 2018 (actual)
- First posted
- 27 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Computed tomographic colonography (CTC), reduced prep | Experimental | Other: Invitation to screeningSubjects invited to undergo CTC with reduced cathartic preparation |
| Computed tomographic colonography (CTC), standard prep | Experimental | Other: Invitation to screeningSubjects invited to undergo CTC with standard bowel preparation |
| Faecal occult blood test (FOBT) | Active comparator | Other: Invitation to screeningSubjects invited to undergo FOBT |
| Colonoscopy | Experimental | Other: Invitation to screeningSubjects invited to undergo colonoscopy |
Who may qualify
- Ages
- 55 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Never invited to previous colorectal cancer screening.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Invitation to screening | Other | Colonoscopy, Computed tomographic colonography (CTC), reduced prep, Computed tomographic colonography (CTC), standard prep, Faecal occult blood test (FOBT) |
Primary outcome
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
2 secondary outcomes
Expected and perceived burden of colonoscopy and CTC
Time frame: 2 years
Number and type of complications in all groups
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2018.
- Derived from this study: PubMed 41025989Puliti D, Sali L, Mascalchi M, Manneschi G, Intrieri T, Caldarella A, Mallardi B, Masala G, Gorini G, Zappa M, Mantellini P. Colorectal Cancer and Advanced Adenoma after Single CT Colonography or Biennial FIT Screening in the SAVE Randomized Controlled Trial. Radiology. 2025 Sep;316(3):e250091. doi: 10.1148/radiol.250091.
- Derived from this study: PubMed 36116454Sali L, Ventura L, Mascalchi M, Falchini M, Mallardi B, Carozzi F, Milani S, Zappa M, Grazzini G, Mantellini P. Single CT colonography versus three rounds of faecal immunochemical test for population-based screening of colorectal cancer (SAVE): a randomised controlled trial. Lancet Gastroenterol Hepatol. 2022 Nov;7(11):1016-1023. doi: 10.1016/S2468-1253(22)00269-2. Epub 2022 Sep 16.
- Derived from this study: PubMed 23497601Sali L, Grazzini G, Carozzi F, Castiglione G, Falchini M, Mallardi B, Mantellini P, Ventura L, Regge D, Zappa M, Mascalchi M, Milani S. Screening for colorectal cancer with FOBT, virtual colonoscopy and optical colonoscopy: study protocol for a randomized controlled trial in the Florence district (SAVE study). Trials. 2013 Mar 15;14:74. doi: 10.1186/1745-6215-14-74.
Related trials for Colorectal Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
RecruitingPhase 1
A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)
Metastatic Colorectal Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefano Milani, MD principal investigator
University of Florence
Grazia Grazzini, MD study director
Cancer Prevention and Research Institute, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Invitation to screening in people with Colorectal Cancer, run by Cancer Prevention and Research Institute, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation rate to faecal occult blood test (FOBT), computed tomographic colonography (CTC) and colonoscopy (time frame: 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01651624, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2018; AzTrials last refreshed its copy on 7 Nov 2026.