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Study on the Establishment and Application of a Model for Monitoring Recurrence and Diagnosis of Non-Muscle-Invasive Bladder Cancer Based on Urinary Exosomes

Study on the Establishment and Application of a Model for Monitoring Recurrence and Diagnosis of Non-Muscle-Invasive Bladder Cancer Based on Urinary Exosomes

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500114423
Enrollment
Unknown
Registered
2025-12-11
Start date
2024-04-15
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

Bladder cancer

Interventions

Gold Standard:Pathology results of TURBT or cystoscopy
Index test:mRNA and lncRNA in urinary exosomes

Sponsors

The Second Hospital of Tianjin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Case Group: 1. Age >= 18 years, no gender restrictions; 2. Patients with clinical indications not excluding bladder malignancy, undergoing initial or repeat cystoscopic biopsy or transurethral resection of bladder tumor (TURBT) (initial pathology being non-muscle-invasive bladder cancer), with positive postoperative pathology; 3. Able to sign an informed consent form, willing to comply with protocol requirements, demonstrate good compliance, and cooperate with center follow-up. Control Group: 1. Age >= 18 years, no gender restrictions; 2. Healthy individuals or patients clinically diagnosed with benign urological conditions, including: urinary tract stones, renal cysts, ureteral strictures, urethral strictures, hypospadias, benign prostatic hyperplasia, urinary tract infections, chronic prostatitis, adenomatous cystitis, and other benign urological diseases; Patients undergoing TURBT for the first time or as a repeat procedure (with initial pathology showing non-muscle-invasive bladder cancer) and receiving negative postoperative pathology or negative combined cystoscopy and urinary cytology results; 3. Able to sign an informed consent form, willing to comply with protocol requirements, demonstrate good compliance, and cooperate with follow-up visits at the participating center.

Exclusion criteria

Exclusion criteria: 1. Individuals with incomplete samples or clinical data; 2. Patients with autoimmune diseases, traumatic conditions, or concurrent systemic tumors; 3. Individuals undergoing systemic chemotherapy, immunotherapy, or radiotherapy prior to urine collection; 4. Patients with urinary tract infections who have received antibiotic treatment within the past five days; 5. Individuals with concurrent urogenital tumors (prostate cancer or renal carcinoma); 6. History of other malignancies within the past five years or prior anticancer therapy.

Design outcomes

Primary

MeasureTime frame
mRNA and lncRNA Expression in Urinary Exosomes;Area Under Curve;Sensitivity;Specificity;

Countries

China

Contacts

Public ContactHailong Hu, Haifang Yin

The Second Hospital of Tianjin Medical University

huhailong@tmu.edu.cn+86 136 6209 6232

Outcome results

None listed

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