Actively Recruiting
Application of a Novel Biomarker Based on Plasma cfDNA Assay in the Early Diagnosis of Prostate Cancer
Led by Shanghai Changzheng Hospital · Updated on 2024-12-27
1100
Participants Needed
1
Research Sites
72 weeks
Total Duration
On this page
Sponsors
S
Shanghai Changzheng Hospital
Lead Sponsor
N
Ningbo No. 1 Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this diagnostic test is to obtain multiple cell-free DNA （cfDNA） fragment profiles of subjects by whole genome sequencing based on plasma cfDNA, build a prostate cancer prediction model by machine learning, and to validate the efficacy of this model in patients who need to undergo needle prostate biopsy base on their prostate-specific antigen（PSA） or clinical or imaging evidence. Therefore, this study aims to explore the efficacy of this prostate cancer prediction model in distinguishing between patients with PSA "gray zone" (4-10 ng/ml) in the diagnosis of prostate cancer and patients with clinically significant prostate cancer.
CONDITIONS
Official Title
Application of a Novel Biomarker Based on Plasma cfDNA Assay in the Early Diagnosis of Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male, 18-80 years old
- PSA level between 4-10 ng/ml
- Scheduled for prostate biopsy with at least one of the following: free PSA/PSA ratio less than 0.16, PSA density greater than 0.15 ng/mL/cm³, PSA velocity greater than 0.75 ng/mL/year, positive digital rectal examination, or suspicious lesions on ultrasound/MRI
You will not qualify if you...
- Prior diagnosis of any malignancy within 5 years
- Previous transurethral resection or enucleation of the prostate
- Prior treatment for prostate cancer including endocrine, targeted, or immunotherapy
- Long-term use of anticoagulant or antiplatelet drugs (anticoagulant stopped less than 1 week ago)
- Any oncological treatment before enrollment such as surgery, radiotherapy, chemotherapy, endocrine, targeted, or immunotherapy
- Serious systemic diseases that may interfere with study treatment or evaluation
- History of organ transplant or non-autologous bone marrow or stem cell transplant
- Blood transfusion within 1 month before blood draw
- Participation in other clinical trials within the last year
- Judged unsuitable by investigator for participation
- Meeting any of the above criteria
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Changzheng hospital
Shanghai, Shanghai Municipality, China, 201109
Actively Recruiting
Research Team
S
Shancheng Ren, MD,PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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