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

NCT ID: NCT07238959

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 1100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2027-12-31

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Retrospective Testing Cohort

Quantum Detection

Intervention Type: DIAGNOSTIC_TEST

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.

Prospective Internal Validation Cohort

Quantum Detection

Intervention Type: DIAGNOSTIC_TEST

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.

Prospective external Validation Cohort

Quantum Detection

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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.

Intervention Type: DIAGNOSTIC_TEST

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.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

West China Hospital

OTHER

Sponsor Role: collaborator

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Ningbo University

NETWORK

Sponsor Role: collaborator

Jiangsu Provincial People's Hospital

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role: collaborator

Shanghai Changzheng Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ren Shancheng

Professor, Chief of Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Ningbo No. 1 Hospital

Ningbo, Zhejiang, China

Countries

China

Central Contacts

Shancheng Ren, MD,PhD

Role: CONTACT

renshancheng@gmail.com

86021-81886999

Duocai Li

Role: CONTACT

Facility Contacts

Fei Liu

Role: primary

liufei_2359@163.com

86010-87787170

Di Gu

Role: primary

sveong@163.com

86020-83062114

Kaoqing Peng

Role: backup

pengkaoqing@163.com

Yuhua Huang

Role: primary

sdfyy_hyh@163.com

860512-65223637

Lu Yang

Role: primary

wycleflue@scu.edu.cn

86028-855422114

Junhui Jiang

Role: primary

13967810448@126.com

860574-87085588

Other Identifiers

CAPS

Identifier Type: -

Identifier Source: org_study_id