NCT07238959

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,100 (estimated)
• Sponsor: Shanghai Changzheng Hospital · Academic / Other
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2025-11-20
• Last updated: 2025-11-20

Locations

7 sites across 1 country: China