Colorectal NeoplasmsNCT02963207
MS Versus NICE for Colorectal Lesions
A study testing Modified Sano's classification and NICE classification in people with Colorectal Neoplasms and Colorectal Polyp, run by Lyell McEwin Hospital.
Trial summary
OBJECTIVE: Our study aimed to compare a recently-developed endoscopic classification with an established one for colorectal lesions in a randomised trial between 2013 and 2015. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Neoplasms, Colorectal Polyp
- What is being tested?
- Modified Sano's classification and NICE classification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 348 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Jun 2015
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients admitted in the Endoscopy Unit for a colonoscopy
- Patients over 18 years-old
- Patients or their caregivers that have understanding of the procedure and that have signed the consent form for the study
Who cannot join
- Patients without colorectal polyps
- Patients with poor bowel preparation
- Patients that do not agree with or withdraw the consent form
About this study
Official title: Prospective Randomised Study Comparing Modified Sano's (MS) Classification and NBI International Colorectal Endoscopic (NICE) for Differentiating Colorectal Lesions
OBJECTIVE: Our study aimed to compare a recently-developed endoscopic classification with an established one for colorectal lesions in a randomised trial between 2013 and 2015.
Read the detailed description
OBJECTIVE: Current practice requires histopathological assessment to confirm diagnosis for colorectal lesions detected at colonoscopy. Advances in endoscopic imaging contribute for real-time diagnosis which, apart from being cost and time-saving, also guides decision-making and reduces risks. Our study aimed to compare a recently-developed endoscopic classification with an established one.
DESIGN: The modified Sano's classification (MS) was compared to the Narrow Band Imaging (NBI) International Colorectal Endoscopic classification (NICE) in a randomised trial between 2013 and 2015. An experimented endoscopist classified each polyp, what was compared to histopathology.
- Conditions
- Colorectal Neoplasms, Colorectal Polyp
- Being tested
- Modified Sano's classification, NICE classification
- Keywords
- colorectal polyp, colorectal lesion, Modified Sano's Classification, NICE classification, NBI, PIVI guidelines, SSA/P, sessile serrated adenoma, sessile serrated polyp
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Sano's classificationOther
Also called MS classification
Set of characteristics described by Singh et al. 2013 to evaluate colorectal lesions.
NICE classificationOther
Also called NBI International Colorectal Endoscopic Classification
Set of characteristics described by Hewett et al. 2012 to evaluate colorectal lesions.
| Study group | Role | What they receive |
|---|---|---|
| Modified Sano's Classification | Experimental | Modified Sano's Classification as described by Singh et al. 2013 Receives: Other: Modified Sano's classification |
| NICE classification | Active comparator | NBI International Colorectal Endoscopic Classification as described by Hewett et al. 2012 Receives: Other: NICE classification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy measures in comparison to the final histopathology in regards to polyps' subtype (neoplastic versus non-neoplastic)
Comparison of NICE or MS with the final histopathology in regards to polyps' subtype (i.e. non-neoplastic = Hyperplastic Polyp (HP) and neoplastic = Sessile Serrated Adenoma/Polyp (SSA/P), Adenomatous Polyp (AP), Traditional Serrated Adenoma (TSA), superficial cancer and invasive cancer)
Measured: After two weeks of the colonoscopy
Accuracy measures in comparison to the final histopathology in regards to polyps' invasiveness
Comparison of NICE or MS with the final histopathology in regards to invasiveness (SSA/P, AP, TSA or superficial cancer versus invasive cancer)
Measured: After two weeks of the colonoscopy
Accuracy measures in comparison to the final histopathology in regards to polyps' subtype (SSA/P versus non-SSA/P)
Comparison of MS with the final histopathology in regards to SSA/P (SSA/P versus non-SSA/P)
Measured: After two weeks of the colonoscopy
Secondary outcomes (2)
Accuracy in regards to negative predictive value of diminutive distal colorectal polyps
Comparison of NICE or MS with the final histopathology in regards to <5 mm distal to the sigmoid polyps (NPV for HPs - according to the PIVI guidelines)
Measured: After two weeks of the colonoscopy
Agreement in predicting post-colonoscopy surveillance interval with final histopathology
Comparison of NICE or MS with the final histopathology in regards to prediction of surveillance interval (according to the PIVI guidelines)
Measured: Immediately after the colonoscopy (endoscopic) and 2 weeks after (histopathology)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2016 (estimated)
- Study startJun 2013
- Primary completionJun 2015
- Study completionJun 2015
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 NeoplasmsStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 348 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lyell McEwin Hospital
- Sponsor type
- Other government
- Collaborators
- University of Adelaide
- Responsible party
- Principal investigator, Leonardo Zorron Cheng Tao Pu, Lyell McEwin Hospital
- Investigators
- Leonardo ZC Pu, MD, MSc, Principal investigator, The Lyell McEwin and The University of Adelaide
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02963207
- Sponsor's protocol ID
- 2008128
- Status last verified
- Nov 2016
- First submitted
- 6 Nov 2016
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Singh R, Jayanna M, Navadgi S, Ruszkiewicz A, Saito Y, Uedo N. Narrow-band imaging with dual focus magnification in differentiating colorectal neoplasia. Dig Endosc. 2013 May;25 Suppl 2:16-20. doi: 10.1111/den.12075.
PubMed 23617643Hewett DG, Kaltenbach T, Sano Y, Tanaka S, Saunders BP, Ponchon T, Soetikno R, Rex DK. Validation of a simple classification system for endoscopic diagnosis of small colorectal polyps using narrow-band imaging. Gastroenterology. 2012 Sep;143(3):599-607.e1. doi: 10.1053/j.gastro.2012.05.006. Epub 2012 May 15.
PubMed 22609383
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomised Study Comparing Modified Sano's (MS) Classification and NBI International Colorectal Endoscopic (NICE) for Differentiating Colorectal Lesions
- ClinicalTrials.gov ID
- NCT02963207
- Acronym / sponsor ID
- 2008128
- Conditions
- Colorectal Neoplasms, Colorectal Polyp
- Keywords
- colorectal polyp, colorectal lesion, Modified Sano's Classification, NICE classification, NBI, PIVI guidelines, SSA/P, sessile serrated adenoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 348 participants (actual)
- Lead sponsor
- Lyell McEwin HospitalOther government
- Collaborators
- University of Adelaide
- Study start
- Jun 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 15 Nov 2016 (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.
OBJECTIVE: Our study aimed to compare a recently-developed endoscopic classification with an established one for colorectal lesions in a randomised trial between 2013 and 2015.
Detailed description
OBJECTIVE: Current practice requires histopathological assessment to confirm diagnosis for colorectal lesions detected at colonoscopy. Advances in endoscopic imaging contribute for real-time diagnosis which, apart from being cost and time-saving, also guides decision-making and reduces risks. Our study aimed to compare a recently-developed endoscopic classification with an established one.
DESIGN: The modified Sano's classification (MS) was compared to the Narrow Band Imaging (NBI) International Colorectal Endoscopic classification (NICE) in a randomised trial between 2013 and 2015. An experimented endoscopist classified each polyp, what was compared to histopathology.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Sano's Classification | Experimental | Other: Modified Sano's classificationModified Sano's Classification as described by Singh et al. 2013 |
| NICE classification | Active comparator | Other: NICE classificationNBI International Colorectal Endoscopic Classification as described by Hewett et al. 2012 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients admitted in the Endoscopy Unit for a colonoscopy
- Patients over 18 years-old
- Patients or their caregivers that have understanding of the procedure and that have signed the consent form for the study
Key exclusion criteria (3 listed)
- Patients without colorectal polyps
- Patients with poor bowel preparation
- Patients that do not agree with or withdraw the consent form
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 |
|---|---|---|
| Modified Sano's classificationAlso: MS classificationSet of characteristics described by Singh et al. 2013 to evaluate colorectal lesions. | Other | Modified Sano's Classification |
| NICE classificationAlso: NBI International Colorectal Endoscopic ClassificationSet of characteristics described by Hewett et al. 2012 to evaluate colorectal lesions. | Other | NICE classification |
Primary outcome
Accuracy measures in comparison to the final histopathology in regards to polyps' subtype (neoplastic versus non-neoplastic)
Time frame: After two weeks of the colonoscopy
Comparison of NICE or MS with the final histopathology in regards to polyps' subtype (i.e. non-neoplastic = Hyperplastic Polyp (HP) and neoplastic = Sessile Serrated Adenoma/Polyp (SSA/P), Adenomatous Polyp (AP), Traditional Serrated Adenoma (TSA), superficial cancer and invasive cancer)
Accuracy measures in comparison to the final histopathology in regards to polyps' invasiveness
Time frame: After two weeks of the colonoscopy
Comparison of NICE or MS with the final histopathology in regards to invasiveness (SSA/P, AP, TSA or superficial cancer versus invasive cancer)
Accuracy measures in comparison to the final histopathology in regards to polyps' subtype (SSA/P versus non-SSA/P)
Time frame: After two weeks of the colonoscopy
Comparison of MS with the final histopathology in regards to SSA/P (SSA/P versus non-SSA/P)
2 secondary outcomes
Accuracy in regards to negative predictive value of diminutive distal colorectal polyps
Time frame: After two weeks of the colonoscopy
Agreement in predicting post-colonoscopy surveillance interval with final histopathology
Time frame: Immediately after the colonoscopy (endoscopic) and 2 weeks after (histopathology)
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 15 Nov 2016.
- Background: PubMed 23617643Singh R, Jayanna M, Navadgi S, Ruszkiewicz A, Saito Y, Uedo N. Narrow-band imaging with dual focus magnification in differentiating colorectal neoplasia. Dig Endosc. 2013 May;25 Suppl 2:16-20. doi: 10.1111/den.12075.
- Background: PubMed 22609383Hewett DG, Kaltenbach T, Sano Y, Tanaka S, Saunders BP, Ponchon T, Soetikno R, Rex DK. Validation of a simple classification system for endoscopic diagnosis of small colorectal polyps using narrow-band imaging. Gastroenterology. 2012 Sep;143(3):599-607.e1. doi: 10.1053/j.gastro.2012.05.006. Epub 2012 May 15.
- Individual participant dataSharing planned: No
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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.
Leonardo ZC Pu, MD, MSc principal investigator
The Lyell McEwin and The University of Adelaide
Questions about this trial
What is this clinical trial studying?
A study testing Modified Sano's classification and NICE classification in people with Colorectal Neoplasms and Colorectal Polyp, run by Lyell McEwin Hospital.
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 3 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 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Accuracy measures in comparison to the final histopathology in regards to polyps' subtype (neoplastic versus non-neoplastic) (time frame: After two weeks of the colonoscopy). The study lists 3 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 NCT02963207, 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 15 Nov 2016.