Colorectal CancerProteusNCT01739608
Participation and Detection Rate of Screening CT Colonography and Screening Sigmoidoscopy
A study testing Invitation to screening in people with Colorectal Cancer, run by Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte at 1 site in Italy.
Trial summary
The objectives of this multicenter, randomized trial is to assess the participation rate achievable through two different screening strategies (Computed Tomographic Colonography-CTC and sigmoidoscopy-FS), to compare detection rate of colorectal cancer (CRC) and advanced adenoma of tests and to evaluate their costs. Read more about this study
- Who is it for?
- Ages 58 to 60 years
- 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
- 40,945 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2013to Dec 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 58 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Asymptomatic individuals, at average risk for CRC, 58-60 years old.
Who cannot join
- Personal history of CRC or polyps
- Family history of CRC or polyps
- A terminal illness or inflammatory bowel disease
- Previous five years complete colonoscopy or a FOBT within the previous 2 years
- Patients who are unable to give informed consent
Trial locations and contacts
1 site in 1 country.
Italy1 site
S.C.D.O. Epidemiologia dei Tumori - Azienda Ospedaliera S. Giovanni Battista di Torino
Turin, Piedmont, 10123
About this study
Official title: Assessment of the Participation Rate and the Diagnostic Accuracy of a Colorectal Cancer Screening Program: CT Colonography Versus Flexible Sigmoidoscopy. Evaluation of a New Model Based on Telediagnosis
The objectives of this multicenter, randomized trial is to assess the participation rate achievable through two different screening strategies (Computed Tomographic Colonography-CTC and sigmoidoscopy-FS), to compare detection rate of colorectal cancer (CRC) and advanced adenoma of tests and to evaluate their costs. The role of Computer-aided detection (CAD) for CTC screening will be also assessed. The trial involves 10 Italian centers located in the Piedmont Region and in Verona. Residents aged 58-60 years in those districts are target for recruitment. Exclusion criteria include: previous diagnosis of cancer or adenoma; family history or hereditary syndromes; personal history of inflammatory bowel disease; patients screened by colonoscopy or FOBT within 2 years; severe disease.
Read the detailed description
Design:
- To compare detection of advanced neoplasia of CT colonography (CTC) to sigmoidoscopy (FS), a total of 20.000 eligible individuals living in the target areas are mailed an invitation letter to participate in the trial. All invitees are asked to call the screening centre in order to receive detailed information about study protocol, the screening examinations and the bowel preparation. Responders who consent to participate in the study are randomly assigned to undergo screening with CTC or FS. All non-responders will be invited to Fecal Occult Blood test (FOBT) according to the current screening procedure. In the CTC arm, positive patients (containing at least one polyp 6 mm or larger) are referred to colonoscopy; negative patients (no polyps >5 mm) are scheduled to be invited to have an FOBT after two years. In the FS arm, positive patients (at least one advanced adenoma found during FS examination) are referred to colonoscopy; negative patients are offered no further follow-up.
- To compare participation rate to FS and CTC, 1200 individuals living in the target areas and never screened for colorectal cancer, are randomly assigned to receive an invitation for screening with CTC or FS. Individuals of both groups 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 CTC contains a phone number of the screening centre. All invitees are asked to call the screening centre in order to receive information about bowel preparation. All non-responders will receive a remainder by mail after one month. Non-responders to reminder will be invited to FS according with current screening procedure. In the CTC arm, positive patients (containing at least one polyp 6 mm or larger) are referred to colonoscopy; negative patients (no polyps >5 mm) are scheduled to be invited to have an FOBT after two years. In the FS arm, positive patients (at least one advanced adenoma found during FS examination) are referred to colonoscopy; negative patients are offered no further follow-up.
- Conditions
- Colorectal Cancer
- Being tested
- Invitation to screening
- Keywords
- CRC
- 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
Invitation to screening
| Study group | Role | What they receive |
|---|---|---|
| CT Colonography (CTC) | Experimental | Invitation to screening. Subject who consent to participate in the study undergo to low dose CTC examination with limited bowel preparation. Receives: Other: Invitation to screening |
| Sigmoidoscopy (FS) | Active comparator | Invitation to screening. Subjects who consent to participate in the study undergo to FS. Receives: Other: Invitation to screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate for cancer and advanced adenoma of CT Colonography versus FS in an invitational CRC screening program
Proportion of subjects detected with CRC or advanced adenomas out of those examined
Measured: three years
Participation rate to FS and CT Colonography
Proportion of subjects attending the proposed examination out of those invited
Measured: one year
Secondary outcomes (3)
Number of participants with severe adverse events in both screening groups
Absolute number of events
Measured: three years
Costs of a CRC screening based on CTC
Unit cost of each procedures for participants
Measured: three years
Type of false positive detections of Computer-aided detection for CTC in a CRC screening program
Characteristics of false positive subjects
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2012 (estimated)
- Study startDec 2013
- Primary completionDec 2014
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 40,945 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
- Sponsor type
- University, hospital or other
- Collaborators
- im3D S.p.A., Regione Piemonte, Candiolo Cancer Institute - IRCCS
- Responsible party
- Sponsor
- Investigators
- Daniele Regge, MD, Principal investigator, Institute for Cancer Research and Treatment at Candiolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01739608
- Sponsor's protocol ID
- 14334-c27.2
- Acronym
- Proteus
- Status last verified
- Jan 2020
- First submitted
- 23 May 2012
- Last updated
- 31 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Regge D, Iussich G, Segnan N, Correale L, Hassan C, Arrigoni A, Asnaghi R, Bestagini P, Bulighin G, Cassinis MC, Ederle A, Ferraris A, Galatola G, Gallo T, Gandini G, Garretti L, Martina MC, Molinar D, Montemezzi S, Morra L, Motton M, Occhipinti P, Pinali L, Soardi GA, Senore C. Comparing CT colonography and flexible sigmoidoscopy: a randomised trial within a population-based screening programme. Gut. 2017 Aug;66(8):1434-1440. doi: 10.1136/gutjnl-2015-311278. Epub 2016 Apr 12.
PubMed 27196588Regge D, Iussich G, Senore C, Correale L, Hassan C, Bert A, Montemezzi S, Segnan N. Population screening for colorectal cancer by flexible sigmoidoscopy or CT colonography: study protocol for a multicenter randomized trial. Trials. 2014 Mar 28;15:97. doi: 10.1186/1745-6215-15-97.
PubMed 24678896
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Participation Rate and the Diagnostic Accuracy of a Colorectal Cancer Screening Program: CT Colonography Versus Flexible Sigmoidoscopy. Evaluation of a New Model Based on Telediagnosis
- ClinicalTrials.gov ID
- NCT01739608
- Acronym / sponsor ID
- Proteus / 14334-c27.2
- Conditions
- Colorectal Cancer
- Keywords
- CRC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40,945 participants (actual)
- Lead sponsor
- Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica PiemonteUniversity, hospital or other
- Collaborators
- im3D S.p.A., Regione Piemonte, Candiolo Cancer Institute - IRCCS
- Study start
- Dec 2013 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 3 Dec 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.
The objectives of this multicenter, randomized trial is to assess the participation rate achievable through two different screening strategies (Computed Tomographic Colonography-CTC and sigmoidoscopy-FS), to compare detection rate of colorectal cancer (CRC) and advanced adenoma of tests and to evaluate their costs. The role of Computer-aided detection (CAD) for CTC screening will be also assessed. The trial involves 10 Italian centers located in the Piedmont Region and in Verona. Residents aged 58-60 years in those districts are target for recruitment. Exclusion criteria include: previous diagnosis of cancer or adenoma; family history or hereditary syndromes; personal history of inflammatory bowel disease; patients screened by colonoscopy or FOBT within 2 years; severe disease.
Detailed description
Design:
- To compare detection of advanced neoplasia of CT colonography (CTC) to sigmoidoscopy (FS), a total of 20.000 eligible individuals living in the target areas are mailed an invitation letter to participate in the trial. All invitees are asked to call the screening centre in order to receive detailed information about study protocol, the screening examinations and the bowel preparation. Responders who consent to participate in the study are randomly assigned to undergo screening with CTC or FS. All non-responders will be invited to Fecal Occult Blood test (FOBT) according to the current screening procedure. In the CTC arm, positive patients (containing at least one polyp 6 mm or larger) are referred to colonoscopy; negative patients (no polyps >5 mm) are scheduled to be invited to have an FOBT after two years. In the FS arm, positive patients (at least one advanced adenoma found during FS examination) are referred to colonoscopy; negative patients are offered no further follow-up.
- To compare participation rate to FS and CTC, 1200 individuals living in the target areas and never screened for colorectal cancer, are randomly assigned to receive an invitation for screening with CTC or FS. Individuals of both groups 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 CTC contains a phone number of the screening centre. All invitees are asked to call the screening centre in order to receive information about bowel preparation. All non-responders will receive a remainder by mail after one month. Non-responders to reminder will be invited to FS according with current screening procedure. In the CTC arm, positive patients (containing at least one polyp 6 mm or larger) are referred to colonoscopy; negative patients (no polyps >5 mm) are scheduled to be invited to have an FOBT after two years. In the FS arm, positive patients (at least one advanced adenoma found during FS examination) are referred to colonoscopy; negative patients are offered no further follow-up.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT Colonography (CTC) | Experimental | Other: Invitation to screeningInvitation to screening. Subject who consent to participate in the study undergo to low dose CTC examination with limited bowel preparation. |
| Sigmoidoscopy (FS) | Active comparator | Other: Invitation to screeningInvitation to screening. Subjects who consent to participate in the study undergo to FS. |
Who may qualify
- Ages
- 58 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Asymptomatic individuals, at average risk for CRC, 58-60 years old.
Key exclusion criteria (5 listed)
- Personal history of CRC or polyps
- Family history of CRC or polyps
- A terminal illness or inflammatory bowel disease
- Previous five years complete colonoscopy or a FOBT within the previous 2 years
- Patients who are unable to give informed consent
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 screeningInvitation to screening | Other | CT Colonography (CTC), Sigmoidoscopy (FS) |
Primary outcome
Detection rate for cancer and advanced adenoma of CT Colonography versus FS in an invitational CRC screening program
Time frame: three years
Proportion of subjects detected with CRC or advanced adenomas out of those examined
Participation rate to FS and CT Colonography
Time frame: one year
Proportion of subjects attending the proposed examination out of those invited
3 secondary outcomes
Number of participants with severe adverse events in both screening groups
Time frame: three years
Costs of a CRC screening based on CTC
Time frame: three years
Type of false positive detections of Computer-aided detection for CTC in a CRC screening program
Time frame: three 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 31 Jan 2020.
- Derived from this study: PubMed 27196588Regge D, Iussich G, Segnan N, Correale L, Hassan C, Arrigoni A, Asnaghi R, Bestagini P, Bulighin G, Cassinis MC, Ederle A, Ferraris A, Galatola G, Gallo T, Gandini G, Garretti L, Martina MC, Molinar D, Montemezzi S, Morra L, Motton M, Occhipinti P, Pinali L, Soardi GA, Senore C. Comparing CT colonography and flexible sigmoidoscopy: a randomised trial within a population-based screening programme. Gut. 2017 Aug;66(8):1434-1440. doi: 10.1136/gutjnl-2015-311278. Epub 2016 Apr 12.
- Derived from this study: PubMed 24678896Regge D, Iussich G, Senore C, Correale L, Hassan C, Bert A, Montemezzi S, Segnan N. Population screening for colorectal cancer by flexible sigmoidoscopy or CT colonography: study protocol for a multicenter randomized trial. Trials. 2014 Mar 28;15:97. doi: 10.1186/1745-6215-15-97.
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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.
Daniele Regge, MD principal investigator
Institute for Cancer Research and Treatment at Candiolo
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 Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte 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 5 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 31 Jan 2020. 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?
Detection rate for cancer and advanced adenoma of CT Colonography versus FS in an invitational CRC screening program (time frame: three years). The study lists 2 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 NCT01739608, which also lists 2 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 31 Jan 2020.