Skip to content

Application of new biomarkers based on plasma cfDNA detection in the early detection of prostate cancer: a single-center study

Application of new biomarkers based on plasma cfDNA detection in the early detection of prostate cancer: a single-center study

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100046274
Enrollment
Unknown
Registered
2021-05-12
Start date
2021-05-06
Completion date
Unknown
Last updated
2021-12-21

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 pathological result
detection

Sponsors

Department of Urology, Shanghai Changhai Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Male, aged <=85 years; 2. Patients who are planning to undergo prostate puncture for diagnosis due to elevated PSA, positive digital rectal examination, or suspected prostate cancer in imaging; 3. Patients who voluntarily participate in this trial after informing the existing diagnosis and treatment plan.

Exclusion criteria

Exclusion criteria: 1. Patients who have been diagnosed with any malignant tumor within the past 5 years; 2. Patients who have previously undergone transurethral resection or enucleation of the prostate; 3. Patients who have undergone prostate puncture due to suspected prostate cancer in the past; 4. Prostate cancer patients who have undergone distant metastasis have been judged by imaging; 5. Patients who have used anticoagulant and antiplatelet aggregation drugs for a long time (the anticoagulant has been stopped for less than 1 week); 6. Before joining the group, received any form of tumor treatment, including surgery, radiotherapy/chemotherapy, endocrine therapy, targeted therapy and immunotherapy; 7. At the same time suffering from other serious systemic diseases, which the investigator believes may interfere with the treatment, evaluation and compliance of this test, including severe respiratory, circulatory, neurological, mental, digestive, endocrine, immune, urinary and other systems disease; 8. Organ transplant subjects or people who have previously undergone non-autologous (allogeneic) bone marrow or stem cell transplantation; 9. Subjects who have undergone blood transfusion 1 month before blood draw; 10. Patients who are participating in other clinical trials, or have participated in other clinical trials and have been completed for less than one year; 11. Patients who are judged by the investigator to be unsuitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Whole-genome high-throughput sequencing of plasma cfDNA;Prostate biopsy results;Patients' clinical and biology information;

Countries

China

Contacts

Public ContactRen Shancheng

Department of Urology, Shanghai Changhai Hospital

renshancheng@gmail.com+86 13917793885

Outcome results

None listed

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