NCT06474338

Brief Summary

The goal of this clinical trial is to learn if the AI algorithm can detect bladder tumors better than urologists under cystoscopy. It will also train the AI algorithm for bladder tumor detection. The main question it aims to answer is: Can AI algorithm achieve IOU value, precision, recall, false negative rate of bladder tumor detection similar to that of urologists? The cystoscopy video will be annotated by AI and urologists. Researchers will compare AI algorithm to urologists to see if Al algorithm has a similar capability as urologists do.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
105mo left

Started Jan 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress21%
Jan 2024Dec 2034

Study Start

First participant enrolled

January 1, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 25, 2024

Completed
9.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2033

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2034

Last Updated

June 25, 2024

Status Verified

June 1, 2024

Enrollment Period

10 years

First QC Date

June 19, 2024

Last Update Submit

June 19, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • intersection over union

    The overlapping area of the actual bladder lesion and detected bladder lesion divided by their combined areas.

    From Jan 1st 2024 to Dec 31st 2033

Study Arms (2)

detection by artificial intelligence

The patient with bladder lesion confirmed by cystoscopy, these bladder lesion(s) are detected by artificial intelligence algorithm.

Diagnostic Test: detection by artificial intelligence

detection by urologists.

The patient with bladder lesion confirmed by cystoscopy, these bladder lesion(s) are detected by urologist.

Diagnostic Test: detection by urologists

Interventions

The bladder lesion(s) are detected by artificial intelligence algorithm.

detection by artificial intelligence

The bladder lesion(s) are detected by urologists.

detection by urologists.

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients with benign or malignant bladder lesion.

You may qualify if:

  • The patient who receives cystoscopy and the cystoscopy video is available, and one or multiple bladder lesions can be observed in the cystoscopy.

You may not qualify if:

  • The patient whose cystoscopy is not clear enough to analyze.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Zixing Ye

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2024

First Posted

June 25, 2024

Study Start

January 1, 2024

Primary Completion (Estimated)

December 31, 2033

Study Completion (Estimated)

December 31, 2034

Last Updated

June 25, 2024

Record last verified: 2024-06

Locations