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A prospective retrospective two-way cohort study of early diagnosis and risk stratification of prostate cancer based on urine liquid biopsy

A prospective retrospective two-way cohort study of early diagnosis and risk stratification of prostate cancer based on urine liquid biopsy

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200059901
Enrollment
Unknown
Registered
2022-05-13
Start date
2022-05-01
Completion date
Unknown
Last updated
2024-04-08

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:Histopathological examination of prostate biopsy
Index test:Urine DNA methylation and gene copy number variation were sequenced by WGBS.

Sponsors

PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Age is equal to or greater than 18 years old and less than 90 years old when signing the informed consent form 2. Men with suspected prostate cancer as determined by elevated serum PSA level, positive digital rectum examination, and/or positive findings from imaging examinations, PSMA PET-CT/MR who plan to undergo prostate biopsy to confirm the diagnosis 3. Patients with prostate cancer diagnosed by prostate biopsy and planned to undergo radical prostatectomy, endocrine therapy or radiotherapy; 4. Patients undergoing regular PSA monitoring after radical prostatectomy; 5. Estimated survival > 12 months; 6. Consent and able to carry out follow-up visit and cooperate with all other study procedures.

Exclusion criteria

Exclusion criteria: 1. Severe disease or other medical conditions suggesting a high risk of death within 1 year, which may interfere with follow-up. Decided by investigator; 2. Prior transurethral enucleation resection of the prostateor Prostate radiotherapy; 3. Diagnosed with any other malignant tumor within 5 years before enrollment; 4. Unable to provide necessary follow-up information; 5. Other conditions that are judged as ineligible by the investigator.

Design outcomes

Primary

MeasureTime frame
DNA methylation;gene copy number variation;

Countries

China

Contacts

Public ContactXu Zhang

PLA General Hospital

xzhang@foxmail.com+86 13795314196

Outcome results

None listed

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