Application of a Novel Model Based on Plasma cfDNA Assay and MRl Lmaging in the Detection of Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 1,600
- 试验地点
- 10
- 主要终点
- AUROC value for predicting positive needle biopsy results (prostate cancer) in individuals with PSA levels in the gray zone.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Patients with elevated PSA test results (4-10ng/ml)
干预措施: Blood draw and MRI scans (Diagnostic Test)
结局指标
主要结局
AUROC value for predicting positive needle biopsy results (prostate cancer) in individuals with PSA levels in the gray zone.
时间窗: Through completion of study and all data analysis which may take up to one and a half years.
Sensitivity for predicting positive needle biopsy results (prostate cancer) in individuals with PSA levels in the gray zone.
时间窗: Through completion of study and all data analysis which may take up to one and a half years.
Specificity for predicting positive needle biopsy results (prostate cancer) in individuals with PSA levels in the gray zone.
时间窗: Through completion of study and all data analysis which may take up to one and a half years.
次要结局
- AUROC value for predicting clinically significant prostate cancer in pathological results.(Through completion of study and all data analysis which may take up to one and a half years.)
研究者
Ren Shancheng
Professor，Chief of Urology
Shanghai Changzheng Hospital