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ClinicalTrials.gov ID

NCT07238959

Lead Sponsor

Shanghai Changzheng HospitalOTHER

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

1,100Estimated

Last Update Posted

Nov 20, 2025Actual

Start Date

Dec 2025Estimated

Primary Completion Date

Dec 2026Estimated

Completion Date

Dec 2027Estimated

Official Title

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

Brief 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.

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

• Quantum Detection

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

Male

Accepts Healthy Volunteers

Yes

Eligibility Criteria

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.

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Shanghai Changzheng HospitalOTHER

Collaborators

West China HospitalOTHER

Cancer Institute and Hospital, Chinese Academy of Medical SciencesOTHER

The First Affiliated Hospital of Guangzhou Medical UniversityOTHER

First Affiliated Hospital of Ningbo UniversityNETWORK

Jiangsu Provincial People's HospitalOTHER

The First Affiliated Hospital of Soochow UniversityOTHER

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