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

NCT07238959 | Not Yet Recruiting DMC

• 1 other identifier: CAPS
• Study Type: observational
• Target: 1,100
• Locations: 1 country
• Sites: 7

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

Keywords

Early diagnosis; cfDNA

Outcome Measures

Primary Outcomes (3)

• 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.

Secondary Outcomes (3)

• Area under the ROC curve for the predictive model in identifying prostate cancer within the PSA grey zone cohort.

  Through primary completion which may take 12 months.

• Sensitivity of the predictive model in identifying prostate cancer within the PSA grey zone cohort.

  Through primary completion which may take 12 months.

• The specificity of the predictive model in identifying prostate cancer among individuals in the PSA grey zone.

  Through primary completion which may take 12 months.

Study Arms (3)

Retrospective Testing Cohort

Diagnostic Test: Quantum Detection

Prospective Internal Validation Cohort

Diagnostic Test: Quantum Detection

Prospective external Validation Cohort

Diagnostic Test: Quantum Detection

Interventions

Quantum Detection 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.

Retrospective Testing Cohort

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Males aged 18-80 years with elevated PSA (\>4 ng/ml) and clinical indications for prostate biopsy.

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai Changzheng Hospital: lead
• 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

Study Sites (7)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

Location

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Location

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 201209, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

Ningbo No. 1 Hospital

Ningbo, Zhejiang, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

This study will extract and analyze cell-free DNA (cfDNA) from participants' peripheral blood. The study protocol does not plan for the long-term retention of any biospecimens. Upon completion of the cfDNA analysis, all remaining DNA samples will be securely disposed of. Only the de-identified derived data from the analyses will be retained for statistical analysis in this study.

MeSH Terms

Conditions

Prostatic Hyperplasia; Prostatic Neoplasms; Disease

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Shancheng Ren, MD,PhD

CONTACT

86021-81886999; renshancheng@gmail.com

Duocai Li

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief of Urology

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: November 20, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)