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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-80
SponsorShanghai Changzheng Hospital

About this trial

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 criteria

Qualifiers

Male, aged 18-80 years;

PSA > 4 ng/ml;

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.

Disqualifiers

Patients diagnosed with any malignant tumour within the past five years;

Patients who have undergone transurethral resection or enucleation of the prostate;

Patients who have previously received treatment for prostate cancer, including but not limited to endocrine therapy, targeted therapy, or immunotherapy;

Patients on long-term anticoagulant or antiplatelet therapy (anticoagulants discontinued for less than one week);

Trial design

Treatments tested in this trial

  • Quantum Detection
  • Quantum Detection
  • Quantum Detection

Treatment groups

1,100 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Shanghai Changzheng Hospital

Lead sponsor

West China Hospital

Collaborator

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Collaborator

The First Affiliated Hospital of Guangzhou Medical University

Collaborator

First Affiliated Hospital of Ningbo University

Collaborator

Jiangsu Provincial People's Hospital

Collaborator

The First Affiliated Hospital of Soochow University

Collaborator