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

Naval Military Medical University (Second Military Medical University)

Status

Not yet enrolling

Conditions

Benign Prostate Hypertrophy(BPH)

Prostate Neoplasm

Prostate Cancer (Diagnosis)

Treatments

Diagnostic Test: Quantum Detection

Study type

Observational

Funder types

Other

NETWORK

Identifiers

NCT07238959

CAPS

Details and patient eligibility

About

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.

Enrollment

1,100 estimated patients

Sex

Male

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male, aged 18-80 years;
PSA > 4 ng/ml;
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

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);
Patients who have received any form of tumour treatment prior to enrolment blood sampling, including surgery, radiotherapy/chemotherapy, endocrine therapy, targeted therapy, or immunotherapy;
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;
Organ transplant recipients or individuals with prior non-autologous (allogeneic) bone marrow or stem cell transplantation;
Subjects who have undergone blood transfusion within one month prior to blood sampling;
Patients currently participating in other clinical trials, or who have participated in other clinical trials within the past year;
Patients deemed unsuitable for this clinical trial by the investigator;
Patients meeting any of the above criteria shall not be eligible for inclusion as subjects.