- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04111601
BLI Based Adenoma Surveillance Strategy (BLAST)
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
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Hampshire
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Portsmouth, Hampshire, United Kingdom, PO6 3LY
- Portsmouth Hospital NHS Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- > 18 years of age Able to provide informed consent
Exclusion Criteria:
- History of polyposis syndrome History of Inflammatory bowel disease History of poor bowel prep
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of adenomas correctly identified with BLI
Time Frame: 12 months
|
Accuracy of BLI in optical diagnosis of small colorectal polyps
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12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Amount of money saved in GBP ( Cost savings)
Time Frame: 12 months
|
Economic implications of replacing histological diagnosis with optical diagnosis
|
12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Pradeep Z Bhandari, Prof, Portsmouth Hospitals NHS Trust
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHT/2019/30
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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