Bladder Cancer
Conditions
Keywords
AI, Uro-Cam, Bladder Cancer
Brief summary
This is a single-arm study investigating the safety, feasibility and diagnostic performance of AI-assisted Uro-Cam catheter assessment that will be performed at the Prince of Wales Hospital. All patients who are referred to the urology outpatient clinic for hematuria workup, and bladder cancer patients who require follow-up cystoscopy, will be screened for study eligibility. If eligible, patients will be recruited into the study with a proper informed consent. All recruited patients will undergo the AI-assisted Uro-Cam catheter assessment followed by a conventional flexible cystoscopy. The study will be conducted in accordance with the Declaration of Helsinki, and it will be registered in ClinicalTrials.gov. An AI-assisted Uro-Cam catheter assessment will be arranged for all recruited study subjects. After the AI-assisted Uro- Cam catheter assessment, a conventional flexible cystoscopy will be conducted in the same session. Biopsy will be taken from any suspicious lesion detected upon AI-assisted Uro-Cam catheter assessment or conventional flexible cystoscopy. After all the procedures, an End-of-study visit will be arranged 4-6 weeks later. The primary outcomes include 30-day complications, and the technical success rate of the AI-assisted Uro-Cam catheter assessment. 30-day complications will be assessed and grading according to the Clavien-Dindo classification. Technical success is defined by the completion of the whole Uro-Cam catheter assessment. The secondary outcomes include the AUC, sensitivity, specificity, positive predictive value, and negative predictive value in detecting histologically confirmed bladder cancer.
Interventions
DEVICEAI Uro-Cam
As stated in AI Uro-Cam arm description
Sponsors
Chinese University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
This is a pilot study investigating the safety, feasibility and diagnostic performance of AI-assisted Uro-Cam catheter assessment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or above * Fulfil any one of the following three criteria: (1) Macroscopic haematuria or persistent microscopic haematuria (microscopic haematuria in at least two urine tests), (2) Abnormal urine cytology results (Atypical cells in at least two urine cytology tests, OR Suspicious cells or malignant cells in at least one urine cytology test), (3)History of non-muscle-invasive bladder cancer with complete transurethral resection of bladder tumour performed
Exclusion criteria
* Presence of clinically significant cardiovascular disease (History of acute myocardial infarction, presence of uncontrolled angina within 3 months before screening, New York Heart Association Class III or IV congestive heart failure, presence of ventricular arrhythmias, or presence of second-degree or third-degree heart block) * Any evidence of active urinary tract infection * Presence of GOLD Stage III or IV chronic obstructive pulmonary disease * ECOG performance status ≥ 2 (Ambulatory and capable of all self-care but unable to carry our any work activities) * History of bleeding disorder or use of anti-coagulants * Presence of other active malignancy * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30-day complications | Thirty days after the allocated treatment | 30-day complications will be assessed and grading according to the Clavien-Dindo classification. |
| Technical success rate | Immediately post-operative | Technical success is defined by the completion of the whole Uro-Cam catheter assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Performance Evaluation | Thirty days after the allocated treatment | AUC, sensitivity, specificity, positive predictive value and negative predictive value in detecting bladder cancer will also be evaluated and recorded. |
Countries
Hong Kong
Contacts
CONTACTJeremy Yuen Chun TEOH, MBBS, FRCSEd
PRINCIPAL_INVESTIGATORJeremy Yuen Chun TEOH, MBBS, FRCSEd
Chinese University of Hong Kong
Outcome results
None listed