Status:
RECRUITING
Application of a Novel Biomarker Based on Plasma cfDNA Assay in the Early Diagnosis of Prostate Cancer
Lead Sponsor:
Shanghai Changzheng Hospital
Collaborating Sponsors:
Ningbo No. 1 Hospital
The First Affiliated Hospital of Guangzhou Medical University
Conditions:
Prostate Cancer
Eligibility:
MALE
18-80 years
Brief Summary
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...
Eligibility Criteria
Inclusion
- Male, 18-80 years old;
- PSA: 4-10ng/ml;
- Patients scheduled for prostate biopsy：
- fPSA（free PSA）/PSA \< 0.16 or PSAD（PSA density） \> 0.15 (ng/mL/cm³) or PSAV（PSA velocity） \> 0.75 (ng/mL/year) ② positive DRE （digital rectal examination） ③suspicious positive lesions on ultrasound/MRI).
Exclusion
- Patients with a prior diagnosis of any malignancy within 5 years;
- Patients who have undergone prior transurethral resection or enucleation of the prostate;
- Patients who have received prior treatment for prostate cancer, including but not limited to endocrine therapy, targeted therapy, and immunotherapy;
- Patients with long-term use of anticoagulant and antiplatelet aggregation drugs (anticoagulant discontinued for less than 1 week);
- Received any form of oncological treatment, including surgery, radiotherapy/chemotherapy, endocrine therapy, targeted therapy, and immunotherapy prior to enrollment for blood sampling;
- concurrently suffering from other serious systemic diseases that, in the opinion of the investigator, may interfere with the treatment, evaluation and compliance of this trial, including serious respiratory, circulatory, neurological, psychiatric, gastrointestinal, endocrine, immune, urinary and other systemic diseases;
- Organ transplant recipients or prior non-autologous (allogeneic) bone marrow or stem cell transplant population;
- Subjects who have had a blood transfusion 1 month prior to the blood draw;
- Patients who are participating in other clinical trials, or who have participated in other clinical trials that have been completed less than 1 year ago;
- Patients who, in the judgment of the investigator, are not suitable for participation in this clinical trial;
- Patients who meet any of the above criteria may not be included as subjects.
Key Trial Info
Start Date :
July 9 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
1100 Patients enrolled
Trial Details
Trial ID
NCT06509919
Start Date
July 9 2024
End Date
December 1 2025
Last Update
December 27 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Changzheng hospital
Shanghai, Shanghai Municipality, China, 201109