Narrow-band Imaging Diagnostic Classification System for Bladder Tumors

NCT05611762 | Unknown

• 1 other identifier: KYLL2021010
• Study Type: observational
• Target: 1,064
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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

Urinary Bladder Neoplasms

Keywords

Urinary Bladder Neoplasms; Narrow-banding Imaging; Diagnosis; Cystoscopy

Outcome Measures

Primary Outcomes (3)

• Cystoscopic WLC and NBI microscopic manifestations, observation of normal mucosa, benign and malignant lesions, morphological characteristics of focal mucosa and submucosal vessels.

  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.

  Cystoscopy 0 days

• Analysis of the accuracy of categorical diagnostic criteria

  Including sensitivity, specificity, area under the ROC curve, positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio, accuracy, Jouden index

  One year

• Based on pathological diagnosis results, evaluate the number of patients with normal mucosa, benign lesions, malignant tumors, and NBI image characteristics

  Pathology results are not only the "gold standard" for grouping, but also for assessing the characteristics of NBI images.

  Follow-up period - 7 days after cystoscopy

Secondary Outcomes (1)

• Safety observation, adverse event record, combined drug use

  Screening period - within 7 days prior to cystoscopy，Cystoscopy 0 days，Follow-up period - 1 days，Follow-up period - 7 days after cystoscopy after cystoscopy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The subject population of this study was patients who required cystoscopy for definitive diagnosis due to hematuria or bladder occupancy; or patients who were routinely reviewed by cystoscopy after elective urinary bladder tumor resection (TURBT). They are all patients who come to our hospital for examination or re-examination.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University (Qingdao): lead
• Qilu Hospital of Shandong University: collaborator
• The Second Hospital of Shandong University: collaborator
• Shandong Provincial Hospital: collaborator
• Yantai Yuhuangding Hospital: collaborator
• Qianfoshan Hospital: collaborator

Study Sites (1)

Qilu Hospital of Shandong University (Qingdao)

Qingdao, Shandong, 266000, China

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Disease

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jun Chen, PhD

CONTACT

+8618560084873; chenjunxinxiang@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 8 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 10, 2022
• Study Start: January 1, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 19, 2022

Record last verified: 2022-12

Locations

CN (1)