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Study and application of urine DNA in early screening of prostate cancer patients

Study and application of urine DNA in early screening of prostate cancer patients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200057576
Enrollment
Unknown
Registered
2022-03-15
Start date
2022-04-01
Completion date
Unknown
Last updated
2023-10-30

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:Needle biopsy of prostate tumor guided by color doppler ultrasound
Index test:DNA mutation analysis,DNA methylation analysis,PSA

Sponsors

ShenZhen HaploX Biotechnology Co., LTD
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Be able to provide written informed consent and understand and agree to comply with the study requirements; 2. Males older than 18 years of age; 3. Inclusion criteria for prostate cancer patients: Patients diagnosed with prostate cancer by needle biopsy did not receive treatment including castration, antiandrology, radiotherapy and chemotherapy before inclusion; 4. Inclusion criteria for non-prostate cancer patients: patients with benign prostate disease who were excluded from prostate cancer by systematic needle biopsy; 5. Inclusion criteria for healthy men: men without clinical indications of prostate disease; 6. Early screening criteria: patients with PSA>=4ng/ml.

Exclusion criteria

Exclusion criteria: 1. Previous castration and/or anti-male drug therapy, chemotherapy, radiotherapy, etc.; Patients with a history of other malignant tumors; 2. The patient has received a blood transfusion within 3 months or has had a bone marrow transplant in the past; 3. The patient has other major diseases in the recent 3 months and has received corresponding treatment; 4. Alcohol or drug abuse; 5. Other circumstances that the researcher considers may affect the results of the experiment or be unethical.

Design outcomes

Primary

MeasureTime frame
DNA mutation analysis;DNA methylation analysis;Prostate specific antigen;

Countries

China

Contacts

Public ContactZhang Xiaoni

ShenZhen HaploX Biotechnology Co., LTD

xn.zhang@haplox.com+86 15622867836

Outcome results

None listed

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