Screening for Urological Malignancies Using a Urine Exfoliated Cell Fluorescence Assay in a Hematuria Population

NCT07813260 | Recruiting

• 1 other identifier: 2026358
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single-center diagnostic clinical study designed to evaluate the performance of a urine-based immunofluorescence cytology test for the detection of urological malignancies in patients presenting with hematuria. The study will enroll 170 eligible participants who are scheduled for cystoscopy and/or ureteroscopy. Urine samples will be collected prior to endoscopy and subjected to both the index immunofluorescence assay and DNA ploidy analysis, with the results compared against the reference standard of endoscopic biopsy and histopathology. The primary objective is to estimate the sensitivity, specificity, and negative predictive value of the immunofluorescence test. Secondary objectives include evaluating the diagnostic accuracy of DNA ploidy analysis, comparing the two index tests using paired statistical methods (e.g., McNemar's test), and assessing their agreement with the reference standard via Kappa statistics. Sample size calculation, based on an assumed malignancy rate of 15% and a target of at least 23 pathology-confirmed malignant cases, ensures adequate power for the primary comparison. The study will follow standardized operating procedures, with independent, blinded interpretation by trained cytopathologists. Statistical analyses will be performed using R or SPSS, with a two-sided significance level of 0.05. The trial is scheduled to commence in April 2026 and is expected to conclude by June 2027, with the aim of providing evidence for a non-invasive, rapid, and cost-effective screening tool in hematuria populations.

Conditions

UTUC; UC (Urothelial Cancer)

Outcome Measures

Primary Outcomes (3)

• Sensitivity of urine-based immunofluorescence cytology test for detecting urological malignancies

  Proportion of patients with pathologically confirmed urological malignancy who test positive by the urine-based immunofluorescence cytology test.

  Assessed at study completion after final histopathology results are available (approximately December 2026)

• Specificity of urine-based immunofluorescence cytology test for detecting urological malignancies

  Proportion of patients without pathologically confirmed urological malignancy who test negative by the urine-based immunofluorescence cytology test.

  Assessed at study completion after final histopathology results are available (approximately December 2026)

• Negative Predictive Value (NPV) of urine-based immunofluorescence cytology test

  Proportion of patients with a negative test result who are truly free of urological malignancy confirmed by pathology.

  Assessed at study completion after final histopathology results are available (approximately December 2026)

Secondary Outcomes (2)

• Diagnostic performance of DNA ploidy analysis

  Assessed at study completion after final histopathology results are available (approximately December 2026)

• Comparison of diagnostic accuracy between immunofluorescence and DNA ploidy

  Assessed at study completion after final histopathology results are available (approximately December 2026)

Eligibility Criteria

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

Study Population

Patients presenting with hematuria who are scheduled for endoscopic evaluation (cystoscopy/ureteroscopy) for suspected urological malignancies (including bladder, renal pelvic, ureteral, and renal cell cancers) at a single urology center in Shanghai, China.

You may qualify if:

• Presenting with hematuria requiring urological malignancy workup
• Age ≥ 18 years
• Planned to undergo cystoscopy and/or ureteroscopy
• Able to provide written informed consent

You may not qualify if:

• Prior confirmed diagnosis of urological malignancy
• Participation in another clinical trial within 3 months prior to enrollment
• Any clinical condition that, per investigator judgment, may interfere with study execution
• Inadequate urine sample quality or volume

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital

Shanghai, China

RECRUITING

Central Study Contacts

Hai Huang

CONTACT

china+18817875498; hh12295@rjh.com.cn

Study Design

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

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 10, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 5, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: September 10, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)