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Development, validation and clinical application of urine-based markers for non-invasive diagnosis of prostate cancer

Development, validation and clinical application of urine-based markers for non-invasive diagnosis of prostate cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400088843
Enrollment
Unknown
Registered
2024-08-27
Start date
2024-03-11
Completion date
Unknown
Last updated
2024-09-02

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

Conditions

Prostate cancer

Interventions

Gold Standard:Clinical and/or pathological diagnosis
Index test:Molecular genetics testing

Sponsors

Fudan University Shanghai Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: ?Age >= 18 years old; ?Urine sample >= 50mL; ?One of the following conditions must be met: 1) Suspicious patients with elevated PSA, positive DRE or imaging tests, who are proposed to undergo prostate biopsy; 2) Patients with definitive diagnosis of prostate cancer by prostate biopsy, who are proposed to undergo prostate cancer surgery and or endocrine therapy or radiotherapy; 3) Patients clinically diagnosed with benign urinary diseases, including: benign prostatic hyperplasia, prostatitis, urinary stones, renal cysts, ureteral stenosis, urethral stenosis, urethral hypospadias, urinary tract infections, glandular cystitis, and other benign diseases of the urinary system; 4) Patients with other tumors that are clinically or pathologically diagnosed as non-prostate cancer, including bladder cancer, renal cancer, ureteral cancer, and renal pelvis cancer, etc.

Exclusion criteria

Exclusion criteria: ? Patients who have received prior transurethral resection or enucleation of the prostate, prostate radiation therapy; ? Patients who have received endocrine treatment or taking 5a-reductase inhibitors within 6 months; ? Any other condition deemed unsuitable for inclusion by researchers.

Design outcomes

Primary

MeasureTime frame
Sensitivity;Specificity;Accuracy;

Countries

China

Contacts

Public ContactDingwei Ye

Fudan University Shanghai Cancer Center

dwyeli@163.com+86 21 6417 5590

Outcome results

None listed

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