Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AI Uro-Cam.
- Who it may be relevant to
- Registry conditions: Bladder Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pilot Study on Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder Cancer
Overview
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
- Device AI Uro-Cam
As stated in AI Uro-Cam arm description
Primary outcome measures
- 30-day complications [Time frame: Thirty days after the allocated treatment]
- Technical success rate [Time frame: Immediately post-operative]
Secondary outcome measures (1)
- Performance Evaluation [Time frame: Thirty days after the allocated treatment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Hong Kong · 1 center
- Prince of Wales Hospital — Hong Kong
Publications
- Britton JP, Dowell AC, Whelan P. Dipstick haematuria and bladder cancer in men over 60: results of a community study. BMJ. 1989 Oct 21;299(6706):1010-2. doi: 10.1136/bmj.299.6706.1010. PMID 2511941
- Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982 Dec;5(6):649-55. No abstract available. PMID 7165009
- Vogelmeier CF, Criner GJ, Martinez FJ, Anzueto A, Barnes PJ, Bourbeau J, Celli BR, Chen R, Decramer M, Fabbri LM, Frith P, Halpin DM, Lopez Varela MV, Nishimura M, Roche N, Rodriguez-Roisin R, Sin DD, Singh D, Stockley R, Vestbo J, Wedzicha JA, Agusti A. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease 2017 Report. GOLD Executive Summary. Am J Respi PMID 28128970
- Hicks KA, Mahaffey KW, Mehran R, Nissen SE, Wiviott SD, Dunn B, Solomon SD, Marler JR, Teerlink JR, Farb A, Morrow DA, Targum SL, Sila CA, Hai MTT, Jaff MR, Joffe HV, Cutlip DE, Desai AS, Lewis EF, Gibson CM, Landray MJ, Lincoff AM, White CJ, Brooks SS, Rosenfield K, Domanski MJ, Lansky AJ, McMurray JJV, Tcheng JE, Steinhubl SR, Burton P, Mauri L, O'Connor CM, Pfeffer MA, Hung HMJ, Stockbridge NL, PMID 29483172
- Hicks KA, Mahaffey KW, Mehran R, Nissen SE, Wiviott SD, Dunn B, Solomon SD, Marler JR, Teerlink JR, Farb A, Morrow DA, Targum SL, Sila CA, Thanh Hai MT, Jaff MR, Joffe HV, Cutlip DE, Desai AS, Lewis EF, Gibson CM, Landray MJ, Lincoff AM, White CJ, Brooks SS, Rosenfield K, Domanski MJ, Lansky AJ, McMurray JJV, Tcheng JE, Steinhubl SR, Burton P, Mauri L, O'Connor CM, Pfeffer MA, Hung HMJ, Stockbridg PMID 29495982
- Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4. PMID 38572751
- Bastacky S, Ibrahim S, Wilczynski SP, Murphy WM. The accuracy of urinary cytology in daily practice. Cancer. 1999 Jun 25;87(3):118-28. doi: 10.1002/(sici)1097-0142(19990625)87:33.0.co;2-n. PMID 10385442
- Chan ES, Ng CF, Hou SM, Yip SK. Using urine microscopy and cytology for early detection of bladder cancer in male patients with lower urinary tract symptoms. Int Urol Nephrol. 2011 Jun;43(2):289-94. doi: 10.1007/s11255-010-9856-y. Epub 2010 Nov 4. PMID 21053072
Identifiers
NCT: NCT07095751 · CRE 2025.323