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Application of Urine Nucleic Acid in Non-invasive Diagnosis of Prostate Cancer

Application of Urine Nucleic Acid in Non-invasive Diagnosis of Prostate Cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400081119
Enrollment
Unknown
Registered
2024-02-22
Start date
2024-03-01
Completion date
Unknown
Last updated
2024-04-22

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:Pathological diagnosis results after prostate biopsy
Index test:cf-ROBUSTTM methylation library preparation method, Next generation sequencing (NGS), RNA-Seq

Sponsors

The Third Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1.Patients aged = 18 years and 12 months, and an ECOG score of 0-2 points. 4.All samples should have corresponding basic clinical information, including sample ID number (outpatient number, medical record number, contact information and hospital number), gender, age, smoking history, chemical exposure history, family history of prostate cancer and clinical diagnosis information. 5.Control cases of other urinary tract diseases other than prostate cancer (which were eventually clinically diagnosed as non-prostate cancer), including prostatic hyperplasia, prostatitis, urinary tract stones, urinary tract infection, kidney cancer, bladder cancer, ureteral cancer, renal pelvis cancer, etc.

Exclusion criteria

Exclusion criteria: 1.Researchers determine patients with other serious illnesses that may affect follow-up and short-term survival, or any medical reasons that show significant risk of death during the 1-year study period. 2.Samples with missing information, such as sample numbers (outpatient numbers, medical record numbers or hospital numbers, etc.), gender, age, clinical diagnosis and others. 3.Samples that are not fresh or have insufficient sample size to complete all experiments. 4.Other situations deemed unsuitable for inclusion by researchers.

Design outcomes

Primary

MeasureTime frame
DNA Methylation;RNA expression;Sensitivity, SE;Specificity, SP;Accuracy;Positive predicative value, PPV, PV+;Negative predictive value, NPV,PV-;

Secondary

MeasureTime frame
Positive likelihood ratio;Negative likelihood ratio;

Countries

China

Contacts

Public ContactLong Wang

Department of Urology, The Third Xiangya Hospital of Central South University

doctorwanglong@163.com+86 138 7315 1645

Outcome results

None listed

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