Clinical trial · Observational
Narrow-band Imaging Diagnostic Classification System for Bladder Tumors
Establishment of Narrow-band Imaging Diagnostic Classification System for Bladder Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this observational study is to learn about the morphological characteristics of different bladder lesions under narrow-band imaging（NBI） techniques in All patients requiring cystoscopy and biopsy. The main questions it aims to answer are: 1. To clarify the characteristics of different bladder lesions under NBI and to establish a diagnostic classification system for bladder tumors under NBI based on pathological findings. 2. Verify the accuracy of this classification system. Participants will record the morphological characteristics under ordinary white light and NBI during cystoscopy, analyze the pathological characteristics of different tissues corresponding to the NBI characteristics, establish a diagnostic classification system for bladder tumor under NBI using pathological biopsy as the diagnostic standard, and then verify the accuracy of this classification standard through clinical.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Urinary Bladder Neoplasms | Bladder Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Cystoscopic WLC and NBI microscopic manifestations, observation of normal mucosa, benign and malignant lesions, morphological characteristics of focal mucosa and submucosal vessels.
- timeFrame
- Cystoscopy 0 days
- description
- Using the pathological results as the "gold standard", the patients were divided into no lesion group, benign lesion group and malignant lesion group, and the morphological characteristics of normal mucosa, benign and malignant lesions, focal mucosa and submucosa vessels were analyzed against cystoscopic WLC and NBI, respectively, to summarize and establish the classification system of bladder tumor NBI diagnosis.
- measure
- Analysis of the accuracy of categorical diagnostic criteria
- timeFrame
- One year
- description
- Including sensitivity, specificity, area under the ROC curve, positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio, accuracy, Jouden index
- measure
- Based on pathological diagnosis results, evaluate the number of patients with normal mucosa, benign lesions, malignant tumors, and NBI image characteristics
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age between 18 and 75 years old. * Patients who require cystoscopy for definitive diagnosis due to hematuria or bladder occupancy; or patients who are routinely reviewed by cystoscopy after electrodesiccation of urinary bladder tumor (TURBT). * Subjects were able to understand the study content and sign the informed consent form, and were able to actively cooperate and follow the study procedures. Exclusion Criteria: * People with coagulation disorders. * Combined with acute urinary tract infection or postoperative infusion of BCG vaccine. * Urethral stricture or bladder volume too small to perform cystoscopy. * Severe cardiopulmonary dysfunction who cannot tolerate local anesthesia surgery. * Women who are menstruating or more than 3 months pregnant.
References
Publications (0)
Data not yet available