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Application value of combined detection of urine microecology and gene methylation in patients with bladder cancer

Application value of combined detection of urine microecology and gene methylation in patients with bladder cancer

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300070969
Enrollment
Unknown
Registered
2023-04-27
Start date
2023-05-01
Completion date
Unknown
Last updated
2024-10-21

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:pathological diagnosis, Urine exfoliative cytology
Index test:Bladder cancer methylation genes, bladder cancer urine microbes

Sponsors

The First Affiliated Hospital of Naval Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Case Group (1) Age above 18 years old; (2) Understand the purpose of the experiment, sign the informed consent form, and provide 100ml of morning urine; (3) Patients with clinical suspicion of bladder cancer (including bladder cancer originating from urothelium, renal pelvis cancer, ureteral cancer, etc.); (4) Consent to undergo urine cytology examination and have a clear examination report (the pathological report of other hospitals or our hospital can be used). 2. Control group (1) Age above 18 years old; (2) Understand the purpose of the experiment, sign the informed consent form, and provide 100ml of morning urine; (3) Healthy people or patients with clinically diagnosed benign diseases of urinary system, including urolithiasis, renal cyst, ureteral stricture, urethral stricture, hypospadias, benign prostatic hyperplasia, urinary tract infection, chronic prostatitis, cystitis glandalis, etc. 3. Interference group (1) Age above 18 years old; (2) Understand the purpose of the experiment, sign the informed consent form, and provide 100ml of morning urine; (3) Patients with other tumors that were clinically or pathologically diagnosed as non-bladder cancer, including prostate cancer, renal cancer, ureteral cancer, renal pelvis cancer, etc.

Exclusion criteria

Exclusion criteria: 1. Unwillingness to sign informed consent; 2. Pregnant women; 3. Patients with tumors at two or more sites; 4. Patients who could not be diagnosed clinically or pathologically; 5. Patients with radiotherapy and chemotherapy.

Design outcomes

Primary

MeasureTime frame
methylation of gene; microbiology ;

Secondary

MeasureTime frame
ROC curve;

Countries

China

Contacts

Public ContactZhang zhensheng

The First Affiliated Hospital of Naval Medical University

13761178177@163.com+86 13761178177

Outcome results

None listed

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