Colo-rectal CancerOptivistaNCT03515343
Optivista : I-SCAN OE for Optical Diagnosis of Small Colon Polyps
An observational study of Colo-rectal Cancer and Polyps of Colon, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
This prospective randomized clinical trial aims to evaluate the new Optivista system compared to the iScan for his optical diagnosis and interval agreement monitoring with pathology. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Colo-rectal Cancer, Polyps of Colon
- What is being tested?
- Screening colonoscopy according to resect-and-discard strategy
- How many people
- 411 participants
- Where
- 1 siteCanada
- Study dates
- 9 Mar 2018to 31 Mar 2019
- Phase
- Observational
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited at the endoscopy unit at the CHUM, before undergoing an elective colonoscopy.
Who may be able to join
- Signed informed consent
- Aged 45 to 80 years
- Indication for full colonoscopy
Who cannot join
- Known inflammatory bowel disease
- Active colitis
- Coagulopathy
- Familial polyposis syndrome
- Poor general health defined as an ASA class > 3
- Emergency colonoscopies
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier Universitaire de Montréal (CHUM)
Montreal, Quebec
About this study
This prospective randomized clinical trial aims to evaluate the new Optivista system compared to the iScan for his optical diagnosis and interval agreement monitoring with pathology. The Participants will be randomized to be diagnosed by either Optivista or Pentax iScan, and all polyps detected during the procedure, their size, location and morphology will be recorded according to the Paris classification after which all polyps will be resected per standard practices and sent for histopathologic evaluation. Further optical assessments will be performed for all polyps of 1-10 mm in size (WASP, NICE, SANO and SIMPLE classification) after with an analysis of comparison between optical diagnosis and pathology results will be performed.
Read the detailed description
The benefit of colonoscopy screening is based on the detection and removal of polyps neoplastic. However, the vast majority of found polyps do not harbor any risk of non-cancer neoplastic. The resection evaluation and histopathology of these polyps are associated with costs while the contribution to cancer prevention is limited. A new technique (Pentax Optivista) based on visual diagnosis of polyps has been introduced to reduce the costs associated with over-screening, and seems to be more efficient than the Pentax iScan technique.
This research project aims to evaluate the new Optivista system compared to the iScan for his optical biopsy performance and interval agreement monitoring with pathology.
This is a prospective clinical trial for which participants are recruited directly from the colonoscopy clinic. The Participants will be randomized to be diagnosed by either Optivista or Pentax iScan. Endoscope withdrawal will be done in iScan 1 mode for patients randomized to iSan and in Optivista OE2 mode for patients randomized to Optivista.
For all polyps detected during the procedure, their size, location and morphology will be recorded according to the Paris classification after which all polyps will be resected per standard practices and sent for histopathologic evaluation.
Polyps that are between 1-10mm in size (diminutive and small polyps), there will be further assessed according to WASP, NICE, SANO and SIMPLE classifications using white light imaging and using an image-enhancing endoscopy technology that enhances visualisation of the polyp surface and vascular patterns.
Concordance between optical diagnosis and pathology monitoring according to recommendations will be presented as proportions with a 95% CI. The features optical polyp diagnostic test for overall diminutive (1-5mm) polyps and by location in the colon (proximal, distal, colon and rectosigmoid segments) will be presented. For outcome measures secondary factors, including factors that may influence the optical diagnosis, proportional estimates with a 95% confidence interval (CI) will be presented. Concordance between strategies is examined using a marginal homogeneity test (Stuart-Maxwell test). For the comparison of proportions, a chi square test or a Fisher's exact two-sided test will be used, as appropriate.
- Conditions
- Colo-rectal Cancer, Polyps of Colon
- Being tested
- Screening colonoscopy according to resect-and-discard strategy
- Keywords
- Cancer prevention, Endoscopy, Gastroenterology
- Medical subject headings
- Colonic Neoplasms, Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening colonoscopy according to resect-and-discard strategyDiagnostic test
This strategy uses image enhancing techniques and optical diagnosis instead of histopathology assessment with 2 Pentax optical imaging systems (either Optivista or iScan).
| Study group | Role | What they receive |
|---|---|---|
| Optical diagnosis with Optivista | Participants for which the optical diagnosis of detected colorectal polyps will be done with the new technique Pentax Optivista. Receives: Diagnostic Test: Screening colonoscopy according to resect-and-discard strategy | |
| Optical diagnosis with iScan | Participants for which the optical diagnosis of detected colorectal polyps will be done with the oldest technique Pentax iScan. Receives: Diagnostic Test: Screening colonoscopy according to resect-and-discard strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance of Optical diagnosis with the pathology based reference standard
The Optical diagnosis of polyps using Optivista or iScan will be compared with the pathology based reference standard.
Measured: 12 months
Rate of polyps detected of both of the technologies (Optivista and iScan) for Optical diagnosis
Measured: 12 months
Secondary outcomes (7)
Negative predictive value of rectosigmoid neoplastic polyps.
Secondary outcomes and data collection include test characteristics, particularly the negative predictive value of rectosigmoid neoplastic polyps.
Measured: 12 months
Concordance of biopsies with WASP classification
Verification of concordance (yes/no) between histopathological results (biopsies) and WASP classification for polyps up to 10mm in size in conjunction with iScan and Optivista (depending on randomization).
Measured: 12 months
Concordance of biopsies and SIMPLE classification
Verification of concordance (yes/no) between histopathological results (biopsies) and SIMPLE classification for polyps up to 10mm in size in conjunction with iScan and Optivista (depending on randomization).
Measured: 12 months
Concordance of biopsies and SANO classification
Verification of concordance (yes/no) between histopathological results (biopsies) and SANO classification for polyps up to 10mm in size in conjunction with iScan and Optivista (depending on randomization).
Measured: 12 months
Concordance of biopsies and NICE classification
Verification of concordance (yes/no) between histopathological results (biopsies) and NICE classification for polyps up to 10mm in size in conjunction with iScan and Optivista (depending on randomization).
Measured: 12 months
Surveillance recommendation following the colonoscopy
The proportion of patients for whom an immediate surveillance recommendation following the colonoscopy can be directly provided for each approach and how often histopathology polyp examination would have been avoided when using each strategy will be examined.
Measured: 12 months
Evaluate Polyp-Based Resect and Discard model
Surveillance interval agreement of the PBRD strategy compared with pathology-based management according to the 2020 USMSTF guidelines.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2018
- Study start9 Mar 2018
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colo-rectal CancerStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 411 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Pentax Medical
- Responsible party
- Sponsor
- Investigators
- Daniel von Renteln, MD, PhD, Principal investigator, Centre Hospitalier Universitaire de Montréal, Research Center (CRCHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03515343
- Sponsor's protocol ID
- 17.135
- Acronym
- Optivista
- Status last verified
- Mar 2018
- First submitted
- 15 Mar 2018
- Last updated
- 19 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Djinbachian R, Marchand E, Pohl H, Aguilera-Fish A, Bouin M, Deslandres E, Weber A, Bouchard S, Panzini B, von Renteln D. Optical diagnosis of colorectal polyps: a randomized controlled trial comparing endoscopic image-enhancing modalities. Gastrointest Endosc. 2021 Mar;93(3):712-719.e1. doi: 10.1016/j.gie.2020.11.023. Epub 2020 Dec 2.
PubMed 33275913
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optivista : I-SCAN OE for Optical Diagnosis of Small Colon Polyps
- ClinicalTrials.gov ID
- NCT03515343
- Acronym / sponsor ID
- Optivista / 17.135
- Conditions
- Colo-rectal Cancer, Polyps of Colon
- Keywords
- Cancer prevention, Endoscopy, Gastroenterology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 411 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Pentax Medical
- Study start
- 9 Mar 2018 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 3 May 2018 (actual)
- 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.
This prospective randomized clinical trial aims to evaluate the new Optivista system compared to the iScan for his optical diagnosis and interval agreement monitoring with pathology. The Participants will be randomized to be diagnosed by either Optivista or Pentax iScan, and all polyps detected during the procedure, their size, location and morphology will be recorded according to the Paris classification after which all polyps will be resected per standard practices and sent for histopathologic evaluation. Further optical assessments will be performed for all polyps of 1-10 mm in size (WASP, NICE, SANO and SIMPLE classification) after with an analysis of comparison between optical diagnosis and pathology results will be performed.
Detailed description
The benefit of colonoscopy screening is based on the detection and removal of polyps neoplastic. However, the vast majority of found polyps do not harbor any risk of non-cancer neoplastic. The resection evaluation and histopathology of these polyps are associated with costs while the contribution to cancer prevention is limited. A new technique (Pentax Optivista) based on visual diagnosis of polyps has been introduced to reduce the costs associated with over-screening, and seems to be more efficient than the Pentax iScan technique.
This research project aims to evaluate the new Optivista system compared to the iScan for his optical biopsy performance and interval agreement monitoring with pathology.
This is a prospective clinical trial for which participants are recruited directly from the colonoscopy clinic. The Participants will be randomized to be diagnosed by either Optivista or Pentax iScan. Endoscope withdrawal will be done in iScan 1 mode for patients randomized to iSan and in Optivista OE2 mode for patients randomized to Optivista.
For all polyps detected during the procedure, their size, location and morphology will be recorded according to the Paris classification after which all polyps will be resected per standard practices and sent for histopathologic evaluation.
Polyps that are between 1-10mm in size (diminutive and small polyps), there will be further assessed according to WASP, NICE, SANO and SIMPLE classifications using white light imaging and using an image-enhancing endoscopy technology that enhances visualisation of the polyp surface and vascular patterns.
Concordance between optical diagnosis and pathology monitoring according to recommendations will be presented as proportions with a 95% CI. The features optical polyp diagnostic test for overall diminutive (1-5mm) polyps and by location in the colon (proximal, distal, colon and rectosigmoid segments) will be presented. For outcome measures secondary factors, including factors that may influence the optical diagnosis, proportional estimates with a 95% confidence interval (CI) will be presented. Concordance between strategies is examined using a marginal homogeneity test (Stuart-Maxwell test). For the comparison of proportions, a chi square test or a Fisher's exact two-sided test will be used, as appropriate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optical diagnosis with Optivista | – | Diagnostic Test: Screening colonoscopy according to resect-and-discard strategyParticipants for which the optical diagnosis of detected colorectal polyps will be done with the new technique Pentax Optivista. |
| Optical diagnosis with iScan | – | Diagnostic Test: Screening colonoscopy according to resect-and-discard strategyParticipants for which the optical diagnosis of detected colorectal polyps will be done with the oldest technique Pentax iScan. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited at the endoscopy unit at the CHUM, before undergoing an elective colonoscopy.
Key inclusion criteria (3 listed)
- Signed informed consent
- Aged 45 to 80 years
- Indication for full colonoscopy
Key exclusion criteria (6 listed)
- Known inflammatory bowel disease
- Active colitis
- Coagulopathy
- Familial polyposis syndrome
- Poor general health defined as an ASA class > 3
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 |
|---|---|---|
| Screening colonoscopy according to resect-and-discard strategyThis strategy uses image enhancing techniques and optical diagnosis instead of histopathology assessment with 2 Pentax optical imaging systems (either Optivista or iScan). | Diagnostic test | Optical diagnosis with Optivista, Optical diagnosis with iScan |
Primary outcome
Concordance of Optical diagnosis with the pathology based reference standard
Time frame: 12 months
The Optical diagnosis of polyps using Optivista or iScan will be compared with the pathology based reference standard.
Rate of polyps detected of both of the technologies (Optivista and iScan) for Optical diagnosis
Time frame: 12 months
7 secondary outcomes
Negative predictive value of rectosigmoid neoplastic polyps.
Time frame: 12 months
Concordance of biopsies with WASP classification
Time frame: 12 months
Concordance of biopsies and SIMPLE classification
Time frame: 12 months
Concordance of biopsies and SANO classification
Time frame: 12 months
Concordance of biopsies and NICE classification
Time frame: 12 months
Surveillance recommendation following the colonoscopy
Time frame: 12 months
Evaluate Polyp-Based Resect and Discard model
Time frame: 12 months
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 19 Jul 2021.
- Derived from this study: PubMed 33275913Djinbachian R, Marchand E, Pohl H, Aguilera-Fish A, Bouin M, Deslandres E, Weber A, Bouchard S, Panzini B, von Renteln D. Optical diagnosis of colorectal polyps: a randomized controlled trial comparing endoscopic image-enhancing modalities. Gastrointest Endosc. 2021 Mar;93(3):712-719.e1. doi: 10.1016/j.gie.2020.11.023. Epub 2020 Dec 2.
Related trials for Colo-rectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
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.
Daniel von Renteln, MD, PhD principal investigator
Centre Hospitalier Universitaire de Montréal, Research Center (CRCHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colo-rectal Cancer and Polyps of Colon, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 6 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 19 Jul 2021. 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 Canada. 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?
Concordance of Optical diagnosis with the pathology based reference standard (time frame: 12 months). 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 NCT03515343, which also lists 1 linked publication.
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 19 Jul 2021.