Cystoscopic Imaging Collection and Enhancement pROject

NCT02427321 | Completed

• 1 other identifier: PR-14056
• Study Type: observational
• Target: 123
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Urinary Bladder Neoplasms

Keywords

Cystoscopy; Bladder cancer; Bladder imaging

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  Reported following recording of all cystoscopic examinations - approximately 3 months following recruitment of first participant

• Statistical summary

  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.

  Once data collection is complete - approximately 5 months after first patient is recruited

• Expert opinion on usability and reliability

  Once data collection is complete - approximately 5 months after first patient is recruited

Study Arms (1)

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.

Device: Video recording of flexible cystoscopic examination

Interventions

Video recording of flexible cystoscopic examination DEVICE

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

Cystoscopy cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Biosignatures Limited: lead
• Newcastle-upon-Tyne Hospitals NHS Trust: collaborator

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Rakesh Heer, PhD FRCS

  Newcastle University, NICR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2015
• First Posted: April 28, 2015
• Study Start: May 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: January 14, 2016

Record last verified: 2016-01