Barrett EsophagusNCT04478929
Early Detection of Barrett's Esophagus Through Deep Image Retrieval
An observational study of Barrett Esophagus, run by Leigh Taylor at 1 site in United Kingdom.
Trial summary
Barrett's oesophagus is a condition in which the area between the oesophagus and stomach no longer closes, allowing acidic contents of the stomach to enter the oesophagus and damage the lining. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Barrett Esophagus
- What is being tested?
- Gastroscopy
- How many people
- 300 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2020to Aug 2021
- 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: Attending NBT clinic for on OGD phase 1, then later attending NBT clinic due to suspected Barrett's.
Who may be able to join
- Adult
- Attending Southmead Hospital for on OGD
- Has capacity
- Initially any indication, later patients with known Barrett's oesophagus
Who cannot join
- Children (<18)
- Patients without capacity
- Urgent and emergency procedures
- Limited English
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NBT, Southmead Hospital
Bristol, Avon, BS10 5NB
leonard griffiths, 0117 414 6353 ext. 6353, leonard.griffiths@nbt.nhs.uk
About this study
Official title: Early Detection of Cancer in Cases of Barrett's Esophagus Using Robotic Endoscopy Image Analysis Through Deep Image Retrieval
Barrett's oesophagus is a condition in which the area between the oesophagus and stomach no longer closes, allowing acidic contents of the stomach to enter the oesophagus and damage the lining. The project aims to assist clinicians by offering informed biopsy process, in which the system presents the operator with clinical outcomes of patients with visually similar GI tracts. The project goal is to assess the use of artificial intelligence-based similarity detection systems to better inform biopsy placement, increasing the reliability of bi-yearly inspections.
Read the detailed description
The project intention is to acquire secondary endoscopy captured data from clinicians to create a sufficient dataset to train a learning system to achieve the stated objective. The data required will feature footage (images/videos) from inside the oesophagus. The preferred data would contain associated diagnosis notes and description, however, data without diagnosis can still be used. All data can and will be anonymised, as personal information will not be useful in this work.
The data will be labelled by either researchers, or professional clinicians and prepared ready to feed into a chosen learning AI system. Through an iterative learning process, the chosen AI system will learn to discriminate between severity of Barrett's oesophagus and output optimal biopsy target.
- Conditions
- Barrett Esophagus
- Being tested
- Gastroscopy
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GastroscopyDiagnostic test
Routine gastroscopy
| Study group | Role | What they receive |
|---|---|---|
| gastroscopy clinic patients | NBT gastroscopy clinic invited participants. Patients are already due to attend the clinic, and we are inviting them to share their gastroscopy data with our research study. Receives: Diagnostic Test: Gastroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
gastroscopy image data set
Images collected during routine gastroscopy with examination notes
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 posted21 Jul 2020
- Study startAug 2020 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett EsophagusStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leigh Taylor
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research UK
- Responsible party
- Sponsor-investigator, Leigh Taylor, University of the West of England
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04478929
- Sponsor's protocol ID
- REDM0227_RP01
- Status last verified
- Jul 2020
- First submitted
- 15 Jul 2020
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Cancer in Cases of Barrett's Esophagus Using Robotic Endoscopy Image Analysis Through Deep Image Retrieval
- ClinicalTrials.gov ID
- NCT04478929
- Acronym / sponsor ID
- REDM0227_RP01
- Conditions
- Barrett Esophagus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Leigh TaylorUniversity, hospital or other
- Collaborators
- Cancer Research UK
- Study start
- Aug 2020 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 21 Jul 2020 (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.
Barrett's oesophagus is a condition in which the area between the oesophagus and stomach no longer closes, allowing acidic contents of the stomach to enter the oesophagus and damage the lining. The project aims to assist clinicians by offering informed biopsy process, in which the system presents the operator with clinical outcomes of patients with visually similar GI tracts. The project goal is to assess the use of artificial intelligence-based similarity detection systems to better inform biopsy placement, increasing the reliability of bi-yearly inspections.
Detailed description
The project intention is to acquire secondary endoscopy captured data from clinicians to create a sufficient dataset to train a learning system to achieve the stated objective. The data required will feature footage (images/videos) from inside the oesophagus. The preferred data would contain associated diagnosis notes and description, however, data without diagnosis can still be used. All data can and will be anonymised, as personal information will not be useful in this work.
The data will be labelled by either researchers, or professional clinicians and prepared ready to feed into a chosen learning AI system. Through an iterative learning process, the chosen AI system will learn to discriminate between severity of Barrett's oesophagus and output optimal biopsy target.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gastroscopy clinic patients | – | Diagnostic Test: GastroscopyNBT gastroscopy clinic invited participants. Patients are already due to attend the clinic, and we are inviting them to share their gastroscopy data with our research study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Attending NBT clinic for on OGD phase 1, then later attending NBT clinic due to suspected Barrett's.
Key inclusion criteria (4 listed)
- Adult
- Attending Southmead Hospital for on OGD
- Has capacity
- Initially any indication, later patients with known Barrett's oesophagus
Key exclusion criteria (4 listed)
- Children (<18)
- Patients without capacity
- Urgent and emergency procedures
- Limited English
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 |
|---|---|---|
| GastroscopyRoutine gastroscopy | Diagnostic test | gastroscopy clinic patients |
Primary outcome
gastroscopy image data set
Time frame: 12 months
Images collected during routine gastroscopy with examination notes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
- 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.
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 Barrett Esophagus, run by Leigh Taylor 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 21 Jul 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lyndon Winstone, PhD (+4411732 82009, Lyndon.Smith@uwe.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gastroscopy image data set (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 21 Jul 2020.