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A multi-omics study of accurate diagnosis of prostate cancer based on non-invasive urine biopsy

A multi-omics study of accurate diagnosis of prostate cancer based on non-invasive urine biopsy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500099290
Enrollment
Unknown
Registered
2025-03-20
Start date
2024-10-09
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

Prostate cancer

Interventions

Index test:urine multiomics diagnostic model

Sponsors

Fudan University Shanghai Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. People with indications of prostate cancer biopsy, including those with abnormal PSA (PSA=4ng/mL); 2. Age >=18 years old; 3. Understand and accept the meaning of the research; 4. Be able to provide urine sample >=100mL prior to biopsy; 5. Sign informed consent approved by the Ethics Committee (EC); 6. Agree to provide the results of prostate cancer biopsy or surgical pathology;

Exclusion criteria

Exclusion criteria: 1. Prostate biopsy was performed within 6 months; 2. The previous diagnosis of prostate cancer; 3. Prostate surgery was performed within 6 months, such as TURP (transurethral resection of the prostate); 4. Uncontrolled severe infection; 5. Taking drugs or hormones that affect PSA levels in the 3-6 months prior to enrollment; 6. Any conditions that the investigator believes may increase the risk to the subjects or interfere with the execution of the clinical trial; 7. Incomplete samples and clinical data;

Design outcomes

Primary

MeasureTime frame
Sensitivity;Specificity;

Countries

China

Contacts

Public ContactDingwei Ye

Fudan University Shanghai Cancer Center

dwyeli@163.com+86 137 0166 3571

Outcome results

None listed

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