Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT07095751
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-03
First Post:
2025-07-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a pilot study investigating the safety, feasibility and diagnostic performance of AI-assisted Uro-Cam catheter assessment.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-30', 'studyFirstSubmitDate': '2025-07-23', 'studyFirstSubmitQcDate': '2025-07-23', 'lastUpdatePostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '30-day complications', 'timeFrame': 'Thirty days after the allocated treatment', 'description': '30-day complications will be assessed and grading according to the Clavien-Dindo classification.'}, {'measure': 'Technical success rate', 'timeFrame': 'Immediately post-operative', 'description': 'Technical success is defined by the completion of the whole Uro-Cam catheter assessment.'}], 'secondaryOutcomes': [{'measure': 'Performance Evaluation', 'timeFrame': 'Thirty days after the allocated treatment', 'description': 'AUC, sensitivity, specificity, positive predictive value and negative predictive value in detecting bladder cancer will also be evaluated and recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AI', 'Uro-Cam', 'Bladder Cancer'], 'conditions': ['Bladder Cancer']}, 'referencesModule': {'references': [{'pmid': '2511941', 'type': 'BACKGROUND', 'citation': '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': '7165009', 'type': 'BACKGROUND', 'citation': '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': '28128970', 'type': 'BACKGROUND', 'citation': '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 Respir Crit Care Med. 2017 Mar 1;195(5):557-582. doi: 10.1164/rccm.201701-0218PP.'}, {'pmid': '29483172', 'type': 'BACKGROUND', 'citation': "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, Chaitman BR, Temple RJ; Standardized Data Collection for Cardiovascular Trials Initiative (SCTI). 2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials. Circulation. 2018 Feb 27;137(9):961-972. doi: 10.1161/CIRCULATIONAHA.117.033502."}, {'pmid': '29495982', 'type': 'BACKGROUND', 'citation': "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, Stockbridge NL, Chaitman BR, Temple RJ; Standardized Data Collection for Cardiovascular Trials Initiative (SCTI). 2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials. J Am Coll Cardiol. 2018 Mar 6;71(9):1021-1034. doi: 10.1016/j.jacc.2017.12.048."}, {'pmid': '38572751', 'type': 'BACKGROUND', 'citation': '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': '10385442', 'type': 'BACKGROUND', 'citation': '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': '21053072', 'type': 'BACKGROUND', 'citation': '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': '24364522', 'type': 'BACKGROUND', 'citation': 'Sharp VJ, Barnes KT, Erickson BA. Assessment of asymptomatic microscopic hematuria in adults. Am Fam Physician. 2013 Dec 1;88(11):747-54.'}, {'pmid': '3081223', 'type': 'BACKGROUND', 'citation': 'Ritchie CD, Bevan EA, Collier SJ. Importance of occult haematuria found at screening. Br Med J (Clin Res Ed). 1986 Mar 8;292(6521):681-3. doi: 10.1136/bmj.292.6521.681.'}, {'pmid': '34511303', 'type': 'BACKGROUND', 'citation': 'Babjuk M, Burger M, Capoun O, Cohen D, Comperat EM, Dominguez Escrig JL, Gontero P, Liedberg F, Masson-Lecomte A, Mostafid AH, Palou J, van Rhijn BWG, Roupret M, Shariat SF, Seisen T, Soukup V, Sylvester RJ. European Association of Urology Guidelines on Non-muscle-invasive Bladder Cancer (Ta, T1, and Carcinoma in Situ). Eur Urol. 2022 Jan;81(1):75-94. doi: 10.1016/j.eururo.2021.08.010. Epub 2021 Sep 10.'}, {'pmid': '31030828', 'type': 'BACKGROUND', 'citation': 'Peterson LM, Reed HS. Hematuria. Prim Care. 2019 Jun;46(2):265-273. doi: 10.1016/j.pop.2019.02.008. Epub 2019 Apr 1.'}, {'pmid': '37145433', 'type': 'BACKGROUND', 'citation': 'Roth V, Espino-Grosso P, Henriksen CH, Canales BK. Office Cystoscopy Urinary Tract Infection Rate and Cost before and after Implementing New Handling and Storage Practices. Urol Pract. 2021 Jan;8(1):23-29. doi: 10.1097/UPJ.0000000000000162. Epub 2020 May 27.'}, {'pmid': '33991045', 'type': 'BACKGROUND', 'citation': "Khadhouri S, Gallagher KM, MacKenzie KR, Shah TT, Gao C, Moore S, Zimmermann EF, Edison E, Jefferies M, Nambiar A, Mannas MP, Lee T, Marra G, Lillaz B, Gomez Rivas J, Olivier J, Assmus MA, Ucar T, Claps F, Boltri M, Burnhope T, Nkwam N, Tanasescu G, Boxall NE, Downey AP, Lal AA, Anton-Juanilla M, Clarke H, Lau DHW, Gillams K, Crockett M, Nielsen M, Takwoingi Y, Chuchu N, O'Rourke J, MacLennan G, McGrath JS, Kasivisvanathan V; IDENTIFY Study group. The IDENTIFY study: the investigation and detection of urological neoplasia in patients referred with suspected urinary tract cancer - a multicentre observational study. BJU Int. 2021 Oct;128(4):440-450. doi: 10.1111/bju.15483. Epub 2021 Sep 8."}, {'pmid': '34189542', 'type': 'BACKGROUND', 'citation': "O'Connor E, McVey A, Demkiw S, Lawrentschuk N, Murphy DG. Assessment and management of haematuria in the general practice setting. Aust J Gen Pract. 2021 Jul;50(7):467-471. doi: 10.31128/AJGP-03-21-5892."}, {'pmid': '27727385', 'type': 'BACKGROUND', 'citation': 'Matulewicz RS, Meeks JJ. Blood in the Urine (Hematuria). JAMA. 2016 Oct 11;316(14):1508. doi: 10.1001/jama.2016.4716. No abstract available.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nAn 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.\n\nAfter 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or above\n* 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\n\nExclusion Criteria:\n\n* 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)\n* Any evidence of active urinary tract infection\n* Presence of GOLD Stage III or IV chronic obstructive pulmonary disease\n* ECOG performance status ≥ 2 (Ambulatory and capable of all self-care but unable to carry our any work activities)\n* History of bleeding disorder or use of anti-coagulants\n* Presence of other active malignancy\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT07095751', 'briefTitle': 'Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Pilot Study on Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder Cancer', 'orgStudyIdInfo': {'id': 'CRE 2025.323'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AI Uro-Cam', 'description': 'All recruited patients will undergo the AI-assisted Uro-Cam catheter assessment followed by a conventional flexible cystoscopy in the same session. Biopsy will be taken from any suspicious lesion detected upon AI-assisted Uro-Cam catheter assessment or conventional flexible cystoscopy.', 'interventionNames': ['Device: AI Uro-Cam']}], 'interventions': [{'name': 'AI Uro-Cam', 'type': 'DEVICE', 'description': 'As stated in AI Uro-Cam arm description', 'armGroupLabels': ['AI Uro-Cam']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'contacts': [{'name': 'Jeremy Yuen Chun TEOH, MBBS, FRCSEd', 'role': 'CONTACT', 'email': 'jeremyteoh@surgery.cuhk.edu.hk', 'phone': '+852 35052625'}, {'name': 'Sui Yan LAU', 'role': 'CONTACT', 'email': 'beckylau@surgery.cuhk.edu.hk', 'phone': '+852 35053933'}, {'name': 'Chi Fai NG', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ka Fung Peter CHIU', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Chi Hang YEE', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Qinyang LIU', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Jeremy Yuen Chun TEOH, MBBS, FRCSEd', 'role': 'CONTACT', 'email': 'jeremyteoh@surgery.cuhk.edu.hk', 'phone': '+852 35052625'}], 'overallOfficials': [{'name': 'Jeremy Yuen Chun TEOH, MBBS, FRCSEd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jeremy Yuen Chun TEOH', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}