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NCT07238959

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

Sponsor: Shanghai Changzheng Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

MALE

Age Range

18 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

1100

Start Date

2025-12

Completion Date

2027-12

Last Updated

2025-11-20

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

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.

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.

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.

Locations (7)

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