Clinical trial NCT02427321: Cystoscopic Imaging Collection and Enhancement pROject
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Bladder Neoplasms
Keywords: Cystoscopy
Bladder cancer
Bladder imaging
Lead sponsor: Biosignatures Limited
Sponsor class: INDUSTRY
Collaborators: name: Newcastle-upon-Tyne Hospitals NHS Trust
First posted: 2015-04-28
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* patients who are incapable of providing written informed consent agreeing to participation in the study.

Primary outcomes:
measure: Video recording of cystoscopic examination and diagnosis
timeFrame: As time of cystoscopic examination - Visit 1, day 1, diagnostic and pathology information collected for up to 8 weeks following Visit 1
Secondary outcomes:
measure: Expert opinions of clinical team
timeFrame: Reported following recording of all cystoscopic examinations - approximately 3 months following recruitment of first participant
measure: Statistical summary
timeFrame: Once data collection from all participants is complete - approximately 5 months after first patient is recruited
measure: 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.
timeFrame: Once data collection is complete - approximately 5 months after first patient is recruited
measure: Expert opinion on usability and reliability
timeFrame: Once data collection is complete - approximately 5 months after first patient is recruited
Other outcomes:
Locations:
Study officials:
affiliation: Newcastle University, NICR
name: Rakesh Heer, PhD FRCS
role: PRINCIPAL_INVESTIGATOR
References: