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The Establishment and Clinical Translation of a Urine Exosome-Based Early Diagnosis and Recurrence Monitoring Model for Urothelial Carcinoma: A Multicenter Clinical Study

The Establishment and Clinical Translation of a Urine Exosome-Based Early Diagnosis and Recurrence Monitoring Model for Urothelial Carcinoma: A Multicenter Clinical Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400089272
Enrollment
Unknown
Registered
2024-09-04
Start date
2024-09-10
Completion date
Unknown
Last updated
2024-09-09

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

Conditions

urothelial carcinoma

Interventions

Gold Standard:Comprehensive evaluation based on the pathological gold standard, imaging, and other clinical examinations.
Index test:Urine exosome miRNA content

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1) Suspected bladder cancer patients with gross or microscopic hematuria, aged =18 years; 2) Each clinical trial subject's clinical sample should be fresh and sufficient to allow for both the evaluation of the test reagent and urinalysis. 3) All samples must be sourced from outpatient or inpatient specimens in clinical hospitals, and must have a clinical or pathological diagnosis. 4) All samples should be accompanied by corresponding clinical basic information, including: sample ID (outpatient number, medical record number, contact phone number, and inpatient number), gender, age, smoking history, history of chemical exposure, family history of bladder cancer, and clinical diagnosis information. 5) Control cases with other non-bladder cancer urinary system diseases (ultimately clinically diagnosed as not bladder cancer), including benign prostatic hyperplasia, urinary stones, urinary tract infections, kidney cancer, and others. 6) Healthy subjects undergoing physical examination, aged =18 years, with no history of infectious diseases, mental illnesses, or other major diseases, and currently in good health. Female subjects must not be pregnant or breastfeeding at the time of the physical examination.

Exclusion criteria

Exclusion criteria: 1) Samples missing information such as sample ID (outpatient number, medical record number, or inpatient number), gender, age, clinical diagnosis, etc. 2) Samples that are not fresh. 3) Samples with insufficient volume to complete all required tests. 4) Samples that do not meet the basic criteria for the test reagent or comparison method.

Design outcomes

Primary

MeasureTime frame
Urine exosome microRNA;Accuracy;Sensitivity ;Specificity;

Secondary

MeasureTime frame
Positive predicative value;

Countries

China

Contacts

Public ContactGong Yanqing

Peking University First Hospital

yqgong@bjmu.edu.cn+86 134 8865 8965

Outcome results

None listed

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