Colorectal PolypBLASTNCT04111601
BLI Based Adenoma Surveillance Strategy
An observational study of Colorectal Polyp, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Bowel cancer is the third most common cancer in the UK. It develops through smaller growths in the bowel called polyps. Early recognition and removal of these polyps result in prevention of developing bowel cancer in an individual. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Polyp
- What is being tested?
- Blue light imaging
- Type of treatment
- Medical device
- How many people
- 217 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Oct 2019to 15 Oct 2022
- How long will I take part?
- 2 Months
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients undergoing colonoscopy who fulfill eligibility criteria.
Who may be able to join
- > 18 years of age Able to provide informed consent
Who cannot join
- History of polyposis syndrome History of Inflammatory bowel disease History of poor bowel prep
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Portsmouth Hospital NHS Trust
Portsmouth, Hampshire, PO6 3LY
About this study
Official title: BLI Based Adenoma Surveillance Strategy: BLAST Study
Bowel cancer is the third most common cancer in the UK. It develops through smaller growths in the bowel called polyps. Early recognition and removal of these polyps result in prevention of developing bowel cancer in an individual. However, not all polyps will lead to cancer, certain polyps are just growths of normal tissue and can be left in the bowel. We therefore need to know which polyps to remove and which ones to leave. One way of doing this is to have a better look at these polyps. This can be done by new technologies. One of them is called Blue Light Imaging (BLI). This is a new light source at the end of the camera which is activated by the push of a button. It will help us in looking at these polyps more closely.
This helps us decide which polyps to remove and which ones are safe to leave as there is always a small risk in removing a polyp. It would also give us a better idea as to when to repeat the camera test if necessary (endoscopic surveillance). By reducing the number of polyps resected and sent to the pathology labs for diagnosis, the work load on the pathology department is also reduced and in the process, providing cost savings to the Trust, The study aims to see if using Blue Light during endoscopy helps us to identify and characterize small polyps better
Read the detailed description
Advanced endoscopic imaging can facilitate the characterisation of neoplastic and non-neoplastic polyps. Accurate identification of small non-neoplastic polyps (e.g. rectosigmoid hyperplastic polyps) that do not harbour malignant potential can lead to future implementation of a 'resect and discard' or 'diagnose and leave' strategy. However, there is insufficient evidence that endoscopists are able to attain high enough levels of optical diagnostic performance in-vivo in order to implement this strategy safely. Blue Light Imaging (BLI) is a new enhanced imaging technology that enhances mucosal surface and vessel patterns. A specific BLI classification was recently developed to enable better characterisation of colorectal polyps (BLI Adenoma Serrated International Classification - BASIC). The use of this technology with the appropriate classification to enhance its performance has not yet been tested in clinical settings of polyp surveillance and screening colonoscopy amongst general endoscopists.
BLAST is a multicentre prospective observational study which will compare BLI optical diagnosis with histological assessment (as a reference standard) for patients with small polyps (<10mm) identified at colonoscopy.
- Conditions
- Colorectal Polyp
- Being tested
- Blue light imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blue light imagingDevice
Advanced virtual chromoendoscopy
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of adenomas correctly identified with BLI
Accuracy of BLI in optical diagnosis of small colorectal polyps
Measured: 12 months
Secondary outcomes (1)
Amount of money saved in GBP ( Cost savings)
Economic implications of replacing histological diagnosis with optical diagnosis
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 posted1 Oct 2019
- Study start16 Oct 2019
- Primary completion15 Oct 2022
- Study completion15 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal PolypStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 217 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Portsmouth Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- King's College Hospital NHS Trust, Luzerner Kantonsspital, Catharina Ziekenhuis Eindhoven, University Medical Centre Ljubljana, Göteborg University, Humanitas Hospital, Italy, Nuovo Regina Margherita Hospital, MITERA Hospitals, Athens , Greece
- Responsible party
- Sponsor
- Investigators
- Pradeep Z Bhandari, Prof, Principal investigator, Portsmouth Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04111601
- Sponsor's protocol ID
- PHT/2019/30
- Acronym
- BLAST
- Status last verified
- Nov 2022
- First submitted
- 12 Jun 2019
- Last updated
- 30 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymised data regarding ensdoscopic findings and histological diagnosis might be shared with other researchers if the need arises.
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BLI Based Adenoma Surveillance Strategy: BLAST Study
- ClinicalTrials.gov ID
- NCT04111601
- Acronym / sponsor ID
- BLAST / PHT/2019/30
- Conditions
- Colorectal Polyp
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Portsmouth Hospitals NHS TrustOther government
- Collaborators
- King's College Hospital NHS Trust, Luzerner Kantonsspital, Catharina Ziekenhuis Eindhoven, University Medical Centre Ljubljana, Göteborg University, Humanitas Hospital, Italy, Nuovo Regina Margherita Hospital, MITERA Hospitals, Athens , Greece
- Study start
- 16 Oct 2019 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 15 Oct 2022 (actual)
- First posted
- 1 Oct 2019 (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.
Bowel cancer is the third most common cancer in the UK. It develops through smaller growths in the bowel called polyps. Early recognition and removal of these polyps result in prevention of developing bowel cancer in an individual. However, not all polyps will lead to cancer, certain polyps are just growths of normal tissue and can be left in the bowel. We therefore need to know which polyps to remove and which ones to leave. One way of doing this is to have a better look at these polyps. This can be done by new technologies. One of them is called Blue Light Imaging (BLI). This is a new light source at the end of the camera which is activated by the push of a button. It will help us in looking at these polyps more closely.
This helps us decide which polyps to remove and which ones are safe to leave as there is always a small risk in removing a polyp. It would also give us a better idea as to when to repeat the camera test if necessary (endoscopic surveillance). By reducing the number of polyps resected and sent to the pathology labs for diagnosis, the work load on the pathology department is also reduced and in the process, providing cost savings to the Trust, The study aims to see if using Blue Light during endoscopy helps us to identify and characterize small polyps better
Detailed description
Advanced endoscopic imaging can facilitate the characterisation of neoplastic and non-neoplastic polyps. Accurate identification of small non-neoplastic polyps (e.g. rectosigmoid hyperplastic polyps) that do not harbour malignant potential can lead to future implementation of a 'resect and discard' or 'diagnose and leave' strategy. However, there is insufficient evidence that endoscopists are able to attain high enough levels of optical diagnostic performance in-vivo in order to implement this strategy safely. Blue Light Imaging (BLI) is a new enhanced imaging technology that enhances mucosal surface and vessel patterns. A specific BLI classification was recently developed to enable better characterisation of colorectal polyps (BLI Adenoma Serrated International Classification - BASIC). The use of this technology with the appropriate classification to enhance its performance has not yet been tested in clinical settings of polyp surveillance and screening colonoscopy amongst general endoscopists.
BLAST is a multicentre prospective observational study which will compare BLI optical diagnosis with histological assessment (as a reference standard) for patients with small polyps (<10mm) identified at colonoscopy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing colonoscopy who fulfill eligibility criteria.
Key inclusion criteria (1 listed)
- > 18 years of age Able to provide informed consent
Key exclusion criteria (1 listed)
- History of polyposis syndrome History of Inflammatory bowel disease History of poor bowel prep
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 |
|---|---|---|
| Blue light imagingAdvanced virtual chromoendoscopy | Device | – |
Primary outcome
Percentage of adenomas correctly identified with BLI
Time frame: 12 months
Accuracy of BLI in optical diagnosis of small colorectal polyps
1 secondary outcome
Amount of money saved in GBP ( Cost savings)
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 30 Nov 2022.
- Individual participant dataSharing planned: Undecided. Anonymised data regarding ensdoscopic findings and histological diagnosis might be shared with other researchers if the need arises.
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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.
Pradeep Z Bhandari, Prof principal investigator
Portsmouth Hospitals NHS Trust
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 Colorectal Polyp, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
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 1 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 30 Nov 2022. 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 United Kingdom. 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?
Percentage of adenomas correctly identified with BLI (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Nov 2022.