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Development of urinary exosomes-based risk stratification and early diagnosis model for prostate cancer

Development and validation of urinary exosomes-based risk stratification and early diagnosis model for prostate cancer

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300078387
Enrollment
Unknown
Registered
2023-12-07
Start date
2023-08-01
Completion date
Unknown
Last updated
2023-12-10

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:Prostate biopsy
Index test:mRNA and lncRNA in urine exosomes

Sponsors

The Second Hospital of Tianjin Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
40 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Patients with serum PSA 4-20 ng/ml scheduled for a prostate biopsy 2. Patients willing to cooperate and complete the follow-up studies and the related inspections 3. Patients willing to participate in the study and sign an informed consent form

Exclusion criteria

Exclusion criteria: 1. Patients have been diagnosed with prostate cancer 2. Patients with active prostatitis on antibiotics 3. Patients taking medications that influence serum PSA within 6 months 4. Patients with a history of a prior biopsy or invasive treatment for prostatic disease within 6 months

Design outcomes

Primary

MeasureTime frame
prostate cancer antigen 3;Sensitivity;Specificity;Positive predictive value, negative predictive value;—

Secondary

MeasureTime frame
homeobox C6;distal-less homeobox-1;—

Countries

China

Contacts

Public ContactYong Wang, Haifang Yin

The Second Hospital of Tianjin Medical University

wy@tmu.edu.cn+86 151 2228 6696

Outcome results

None listed

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