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Multicenter prospective clinical study on the sensitivity of "WINWH" urine cytology detection technology to bladder cancer

Multicenter prospective clinical study on the sensitivity of "WINWH" urine cytology detection technology to bladder cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400086524
Enrollment
Unknown
Registered
2024-07-04
Start date
2024-07-05
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blader Cancer

Interventions

Gold Standard:Biopsy histopathology results are the gold standard
Index test:The new urine cytology detection technology (Wenwo, WINWH)

Sponsors

Zhengzhou University Second Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria for the experimental group Over 18 years old; Hematuria under the microscope or naked eye; Cystoscopy examination is required and biopsy tissue should be taken. Inclusion criteria for the control group Healthy individuals who underwent physical examinations at our hospital's physical examination center during the same period; Over 18 years old;

Exclusion criteria

Exclusion criteria: Exclusion criteria for the experimental group Cancer of the renal pelvis, ureter, and urethra; ? Have a history of bladder cancer perfusion therapy and systemic chemotherapy within 6 months; History of BCG bladder infusion; Reconstruct the bladder by indwelling a urinary catheter or a bladder fistula tube; Having bladder stones or within 3 months after treatment; Serious urinary tract infection that has not been cured. Exclusion criteria for the control group Previous medical history and treatment history of urinary system tumors (including kidney, renal pelvis, ureter, bladder, prostate, urethral cancer, etc.); Reconstruct the bladder by indwelling a urinary catheter or a bladder fistula tube; Having bladder stones or within 3 months after treatment; Have a history of gross hematuria or microscopic hematuria within the past 6 months; Serious urinary tract infection that has not been cured.

Design outcomes

Primary

MeasureTime frame
Urinary exfoliated cells;Accuracy ;Sensitivity;Specificity ;

Secondary

MeasureTime frame
Positive predicative value;Negative predictive value;

Countries

China

Contacts

Public ContactChangbao Xu

Zhengzhou University Second Affiliated Hospital

evenwangzzu@hotmail.com+86 153 0372 9717

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026