Urinary Bladder NeoplasmsCICERONCT02427321
Cystoscopic Imaging Collection and Enhancement pROject
An observational study of Urinary Bladder Neoplasms, run by Biosignatures Limited.
Trial summary
This study will collect video recordings of routine flexible cystoscopy examinations, medical history and diagnosis information, from up to 100 participants who have a history of bladder cancer, or symptoms suggestive of bladder cancer, in order to develop a new computer system for recording and reviewing images of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Bladder Neoplasms
- What is being tested?
- Video recording of flexible cystoscopic examination
- Type of treatment
- Medical device
- How many people
- 123 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Oct 2015
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adults referred to Urology clinic for cystoscopic surveillance after treatment for bladder cancer, and adults referred for cystoscopic investigation of haematuria or lower urinary tract symptoms (LUTS) that raise the suspicion of an undiagnosed bladder cancer.
Who may be able to join
- patients scheduled to undergo cystoscopy examination as they are considered to possibly have undiagnosed bladder cancer, or;
- patients scheduled to undergo a post-treatment follow-up or routine surveillance cystoscopy examination, having previously been treated for bladder cancer; and
- Have provided written informed consent agreeing to participation in the study prior to any study-specific procedures being carried out.
Who cannot join
- patients who are incapable of providing written informed consent agreeing to participation in the study.
About this study
Official title: Cystoscopic Imaging Collection and Enhancement pROject: A Prospective, Non-randomised, Observational Proof-of-concept Study of Flexible Cystoscopic Examination Recordings From a Symptomatic Adult Population
This study will collect video recordings of routine flexible cystoscopy examinations, medical history and diagnosis information, from up to 100 participants who have a history of bladder cancer, or symptoms suggestive of bladder cancer, in order to develop a new computer system for recording and reviewing images of the bladder, and to assess the utility of this system.
Read the detailed description
Flexible cystoscopy is commonly used in the diagnosis and post-treatment care of bladder cancer, the 7th most common cancer in the United Kingdom. While the equipment to record bladder examinations exists, it is not simple or quick to use so examinations are rarely recorded. Methods of enhancing the images obtained during these examinations also exist but these are generally hardware based, requiring specific equipment, or use a fluorescent dye and special endoscope, which is expensive for the clinical service provider, inconvenient for the patient and may cause allergic reactions.
The new proof-of-concept device will record high-definition video in a lossless format to a computer hard-drive from any existing cystoscopy equipment to which it can be connected. Additionally, the device incorporates a foot pedal which allows the operator to "bookmark" points of interest during the examination. These points are marked in the recorded video data file and aid later navigation and review of examination session videos.
The recordings will be used to develop novel image enhancement software, which is intended to make abnormalities in the bladder easier to identify. Once the software has been developed, the enhanced and un-enhanced videos will be reviewed by experts (clinical urology specialists) and non-experts (other healthcare staff and laypeople), who will be asked to report areas of interest in the videos, without knowledge of the diagnosis for each examination. A statistical analysis of reporting of areas of interest by expert and non-expert reviewers will be produced, to assess the usefulness of the software image enhancement in identifying abnormalities in the bladder.
- Conditions
- Urinary Bladder Neoplasms
- Being tested
- Video recording of flexible cystoscopic examination
- Keywords
- Cystoscopy, Bladder cancer, Bladder imaging
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video recording of flexible cystoscopic examinationDevice
The video feed from the flexible cystoscopic examination will be recorded for all participants in the study. Proof-of-concept device will record high-definition video in a lossless format to a computer hard-drive from any existing cystoscopy equipment
| Study group | Role | What they receive |
|---|---|---|
| Cystoscopy cohort | Video recording of flexible cystoscopic examination. All participants enrolled on the study will have video from their flexible cystoscopic examination recorded.
Diagnosis and pathology information will be collected from the participants medical notes for a period of eight weeks following the recorded cystoscopy. Receives: Device: Video recording of flexible cystoscopic examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Video recording of cystoscopic examination and diagnosis
A set of high quality recorded cystoscopy examinations from 50 to 100 participants. The recordings will be used to develop novel image enhancement software, which is intended to make abnormalities in the bladder easier to identify. The diagnosis reported by the cystoscope operator will be reported at the time of the examination. Pathology derived diagnosis and any other additional information regarding the diagnosis and subsequent treatment will be recorded at 8 weeks following the initial examination (Visit 1, day 1).
Measured: As time of cystoscopic examination - Visit 1, day 1, diagnostic and pathology information collected for up to 8 weeks following Visit 1
Secondary outcomes (4)
Expert opinions of clinical team
Written expert opinions from the clinical team based on structured review of a subset of the recordings in raw and enhanced playback modes, including comments on the quality of the recordings made by the device and their suitability for use as a documentary record of the examination procedure.
Measured: Reported following recording of all cystoscopic examinations - approximately 3 months following recruitment of first participant
Statistical summary
A statistical summary of the inter-observer consistency in reporting 'areas of interest' in raw and enhanced video sequences. This will report on expert and non-expert reviewer results.
Measured: Once data collection from all participants is complete - approximately 5 months after first patient is recruited
Report on 2 and 3 (correspondence between the results of 2) expert opinion and 3)statistical summary, and the diagnostic outcomes logged by the clinic.
A report exploring the correspondence between the results of 2) and 3) and the diagnostic outcomes logged by the clinic.
Measured: Once data collection is complete - approximately 5 months after first patient is recruited
Expert opinion on usability and reliability
Written expert opinions from the clinical team which will comment on the usability and reliability of the device compared to existing recording and documenting systems, including whether use of the device has any adverse impact upon patient safety caused by an increase in the duration or disruption of routine cystoscopy procedures.
Measured: Once data collection is complete - approximately 5 months after first patient is recruited
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosignatures Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Newcastle-upon-Tyne Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Rakesh Heer, PhD FRCS, Principal investigator, Newcastle University, NICR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02427321
- Sponsor's protocol ID
- PR-14056
- Acronym
- CICERO
- Status last verified
- Jan 2016
- First submitted
- 17 Apr 2015
- Last updated
- 14 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cystoscopic Imaging Collection and Enhancement pROject: A Prospective, Non-randomised, Observational Proof-of-concept Study of Flexible Cystoscopic Examination Recordings From a Symptomatic Adult Population
- ClinicalTrials.gov ID
- NCT02427321
- Acronym / sponsor ID
- CICERO / PR-14056
- Conditions
- Urinary Bladder Neoplasms
- Keywords
- Cystoscopy, Bladder cancer, Bladder imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Biosignatures LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Newcastle-upon-Tyne Hospitals NHS Trust
- Study start
- May 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 28 Apr 2015 (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.
This study will collect video recordings of routine flexible cystoscopy examinations, medical history and diagnosis information, from up to 100 participants who have a history of bladder cancer, or symptoms suggestive of bladder cancer, in order to develop a new computer system for recording and reviewing images of the bladder, and to assess the utility of this system.
Detailed description
Flexible cystoscopy is commonly used in the diagnosis and post-treatment care of bladder cancer, the 7th most common cancer in the United Kingdom. While the equipment to record bladder examinations exists, it is not simple or quick to use so examinations are rarely recorded. Methods of enhancing the images obtained during these examinations also exist but these are generally hardware based, requiring specific equipment, or use a fluorescent dye and special endoscope, which is expensive for the clinical service provider, inconvenient for the patient and may cause allergic reactions.
The new proof-of-concept device will record high-definition video in a lossless format to a computer hard-drive from any existing cystoscopy equipment to which it can be connected. Additionally, the device incorporates a foot pedal which allows the operator to "bookmark" points of interest during the examination. These points are marked in the recorded video data file and aid later navigation and review of examination session videos.
The recordings will be used to develop novel image enhancement software, which is intended to make abnormalities in the bladder easier to identify. Once the software has been developed, the enhanced and un-enhanced videos will be reviewed by experts (clinical urology specialists) and non-experts (other healthcare staff and laypeople), who will be asked to report areas of interest in the videos, without knowledge of the diagnosis for each examination. A statistical analysis of reporting of areas of interest by expert and non-expert reviewers will be produced, to assess the usefulness of the software image enhancement in identifying abnormalities in the bladder.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cystoscopy cohort | – | Device: Video recording of flexible cystoscopic examinationVideo recording of flexible cystoscopic examination. All participants enrolled on the study will have video from their flexible cystoscopic examination recorded. Diagnosis and pathology information will be collected from the participants medical notes for a period of eight weeks following the recorded cystoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults referred to Urology clinic for cystoscopic surveillance after treatment for bladder cancer, and adults referred for cystoscopic investigation of haematuria or lower urinary tract symptoms (LUTS) that raise the suspicion of an undiagnosed bladder cancer.
Key inclusion criteria (3 listed)
- patients scheduled to undergo cystoscopy examination as they are considered to possibly have undiagnosed bladder cancer, or;
- patients scheduled to undergo a post-treatment follow-up or routine surveillance cystoscopy examination, having previously been treated for bladder cancer; and
- Have provided written informed consent agreeing to participation in the study prior to any study-specific procedures being carried out.
Key exclusion criteria (1 listed)
- patients who are incapable of providing written informed consent agreeing to participation in the study.
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 |
|---|---|---|
| Video recording of flexible cystoscopic examinationThe video feed from the flexible cystoscopic examination will be recorded for all participants in the study. Proof-of-concept device will record high-definition video in a lossless format to a computer hard-drive from any existing cystoscopy equipment | Device | Cystoscopy cohort |
Primary outcome
Video recording of cystoscopic examination and diagnosis
Time frame: As time of cystoscopic examination - Visit 1, day 1, diagnostic and pathology information collected for up to 8 weeks following Visit 1
A set of high quality recorded cystoscopy examinations from 50 to 100 participants. The recordings will be used to develop novel image enhancement software, which is intended to make abnormalities in the bladder easier to identify. The diagnosis reported by the cystoscope operator will be reported at the time of the examination. Pathology derived diagnosis and any other additional information regarding the diagnosis and subsequent treatment will be recorded at 8 weeks following the initial examination (Visit 1, day 1).
4 secondary outcomes
Expert opinions of clinical team
Time frame: Reported following recording of all cystoscopic examinations - approximately 3 months following recruitment of first participant
Statistical summary
Time frame: Once data collection from all participants is complete - approximately 5 months after first patient is recruited
Report on 2 and 3 (correspondence between the results of 2) expert opinion and 3)statistical summary, and the diagnostic outcomes logged by the clinic.
Time frame: Once data collection is complete - approximately 5 months after first patient is recruited
Expert opinion on usability and reliability
Time frame: Once data collection is complete - approximately 5 months after first patient is recruited
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 14 Jan 2016.
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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.
Rakesh Heer, PhD FRCS principal investigator
Newcastle University, NICR
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Bladder Neoplasms, run by Biosignatures Limited.
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 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 14 Jan 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?
Video recording of cystoscopic examination and diagnosis (time frame: As time of cystoscopic examination - Visit 1, day 1, diagnostic and pathology information collected for up to 8 weeks following Visit 1). 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 14 Jan 2016.