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Clinical Trials in China / NCT07238959
Starting soon Observational

Application of Quantum Detection-Driven Artificial Intelligence Algorithms for Single-Molecule cfDNA Characterization in the Early Diagnosis of Prostate Cancer

NCT07238959 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Changzheng Hospital
Phase
Observational
Started
2025-12
Last updated
2025-11-20

Condition(s) studied

Benign Prostate Hypertrophy(BPH)Prostate Cancer (Diagnosis)Prostate Neoplasm

Investigational drug(s) / intervention(s)

Quantum DetectionQuantum DetectionQuantum Detection

Quantum Detection: This cohort will utilize archived plasma samples from a historical patient population with confirmed diagnoses (prostate cancer vs. controls). The objective is model development. The intervention involves analyzing these stored samples using the quantum sensing platform to extract multi-modal cfDNA features (e.g., fragmentomics, methylation). This data is then used to train and optimize the initial AI diagnostic algorithm, establishing the core model before prospective validation.

Quantum Detection: This cohort will prospectively enroll new patients with suspected prostate cancer from the same institution as testing cohort. The objective is initial model validation. The intervention entails collecting pre-biopsy blood samples from these participants. The cfDNA from these fresh samples is analyzed using the locked model from the training phase. The model's predictions are then compared against the gold-standard prostate biopsy results to assess initial diagnostic performance.

Quantum Detection: This cohort will prospectively recruit patients from multiple independent clinical centers. The objective is to test the model's generalizability. The intervention involves standardized blood collection across all external sites, with samples sent to a central lab for blinded cfDNA analysis using the finalized, locked-down model.

Study summary

This research project aims to develop a novel blood testing method integrating cutting-edge quantum sensing and artificial intelligence technologies to achieve precise, non-invasive early diagnosis of prostate cancer. The research will employ quantum sensors to perform ultra-high-sensitivity measurements of circulating free DNA (cfDNA) in blood, thereby training a dedicated AI diagnostic model. The ultimate objective is to establish the diagnostic efficacy of this approach through clinical validation, providing clinicians with a novel diagnostic tool capable of significantly reducing unnecessary prostate biopsy procedures.

Eligibility

Sex
MALE
Min age
18 Years
Max age
80 Years
Healthy volunteers
Accepted
Inclusion Criteria: 1. Male, aged 18-80 years; 2. PSA \> 4 ng/ml; 3. Patients meeting criteria for prostate biopsy: * fPSA/PSA \< 0.16 or PSA D \> 0.15 or PSA V \> 0.75; ② Positive digital rectal examination (DRE); ③ Imaging studies (ultrasound/MRI) showing suspicious lesions. Exclusion Criteria: 1. Patients diagnosed with any malignant tumour within the past five years; 2. Patients who have undergone transurethral resection or enucleation of the prostate; 3. Patients who have previously received treatment for prostate cancer, including but not limited to endocrine therapy, targeted therapy, or immunotherapy; 4. Patients on long-term anticoagulant or antiplatelet therapy (anticoagulants discontinued for less than one week); 5. Patients who have received any form of tumour treatment prior to enrolment blood sampling, including surgery, radiotherapy/chemotherapy, endocrine therapy, targeted therapy, or immunotherapy; 6. Concurrent severe systemic diseases deemed by the investigator likely to interfere with trial treatment, evaluation, or compliance, including serious respiratory, circulatory, neurological, psychiatric, gastrointestinal, endocrine, immunological, or urological disorders; 7. Organ transplant recipients or individuals with prior non-autologous (allogeneic) bone marrow or stem cell transplantation; 8. Subjects who have undergone blood transfusion within one month prior to blood sampling; 9. Patients currently participating in other clinical trials, or who have participated in other clinical trials within the past year; 10. Patients deemed unsuitable for this clinical trial by the investigator; 11. Patients meeting any of the above criteria shall not be eligible for inclusion as subjects.

Primary outcome measure(s)

  • Area under the receiver operating characteristic curve (AUC-ROC) for the predictive model in the general population for prostate cancer. — Through primary completion which may take 12 months.
  • Sensitivity of the predictive model in detecting prostate cancer within the general population. — Through primary completion which may take 12 months.
  • Specificity of the predictive model in detecting prostate cancer within the general population. — Through primary completion which may take 12 months.

Trial sites (7)

FacilityCityRegionStatus
Cancer Hospital, Chinese Academy of Medical Sciences Beijing Beijing Municipality
The First Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong
Jiangsu Provincial People's Hospital Nanjing Jiangsu
The First Affiliated Hospital of Soochow University Suzhou Jiangsu
Shanghai Changzheng Hospital Shanghai Shanghai Municipality
West China Hospital, Sichuan University Chengdu Sichuan
Ningbo No. 1 Hospital Ningbo Zhejiang

More Shanghai Changzheng Hospital trials in China

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A Dose-Expansion Trial of Intravenous HNF4α srRNA for Unresectable or Metastatic Colorectal Cancer Recruiting
A Clinical Trial Evaluating the Safety and Efficacy of Intravenous CD-801 in Treating Advanced HCC Patients Recruiting
A Study on the Changes of Glucose Metabolism and Exocrine Function in Patients With Chronic Pancreatitis Recruiting
a Study of CT0596 in Relapsed/Refractory Multiple Myeloma and Relapsed/Refractory Plasma Cell Leukemia Recruiting

Other trials for the same condition

CascadeDiagnose Prostate MRI Starting soon
68Ga-XMFH01 PET/Fluorescence Imaging in Prostate Cancer Recruiting
miRNA Panel for PCa Diagnosis Recruiting
Theranostic Applications of Radionuclides in Prostate Cancer Recruiting
The Enhancement of Diagnostic and Grading Efficacy of Prostate Cancer by New MRI Sequences: A Prospective Observational Study Based on New MRI Sequences in a Single Center Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07238959 on ClinicalTrials.gov ↗ ← All trials in China