NCT06991452

Early Diagnosis and Recurrence Monitoring of Colorectal Cancer

Multicenter Clinical Validation of a Novel Strategy for Early Diagnosis and Recurrence Monitoring in Colorectal Cancer

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,200 (estimated)
• Sponsor: Huashan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

Colorectal cancer (CRC) has an insidious onset and its survival rate is closely related to clinical stage. While the 5-year survival rate of stage I patients exceeds 90%, it drops to 14% in stage IV. In China, only 15.2% of CRC cases are diagnosed at stage I, far below the rate in developed countries like the United States (24.1%). Early detection and screening are key to reducing CRC mortality and improving patient outcomes. However, current screening methods-including colonoscopy, fecal immunochemical tests (FIT), and emerging stool or blood-based biomarkers-face limitations such as invasiveness, low sensitivity, high cost, or lack of large-scale clinical validation. Importantly, these methods fail to dynamically reflect tumor evolution or assess prognosis and treatment response. Liquid biopsy has recently emerged as a promising non-invasive strategy for early cancer detection. It enables detection of tumor-related components in body fluids such as circulating tumor DNA (ctDNA), circulating tumor cells (CTCs), tumor-educated platelets (TEPs), exosomes, and cancer-specific proteins. These approaches offer a comprehensive view of tumor heterogeneity, epigenetic modifications, and treatment response. Our multidisciplinary team, from Fudan University, Xiamen University, and Xuzhou Medical University, has previously developed a cfDNA-5hmC-based diagnostic model using 5hmC-Seal technology, achieving 88% sensitivity and 89% specificity in detecting CRC. To further improve tissue specificity and diagnostic accuracy, the investigators integrated multi-omics data and advanced AI techniques (including a Transformer-based deep learning model) to deconvolute tissue origin signals. In parallel, the investigators established a charge-selective CTC enrichment platform and discovered novel metabolic markers such as HPD that may indicate tumor recurrence and metastasis. The investigators team also developed a series of nano-biosensing platforms and tumor-targeting aptamer-based diagnostic kits, some of which have been granted national patents and clinical innovation awards. This observational study will establish a large-scale, multi-center cohort of early-stage CRC patients. The investigators aim to construct a comprehensive multi-omics atlas from liquid biopsy samples, identify early diagnostic and prognostic biomarkers for CRC (including liver metastasis and drug resistance), and develop AI-driven models for non-invasive early detection and recurrence prediction. The study is expected to deliver clinically applicable technologies that improve CRC diagnostic accuracy, enable timely intervention, and reduce mortality. All study procedures will comply with ethical guidelines and be approved by institutional review boards.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Liquid biopsy	Serum protein profile, serum metabolic mass spectrometry, plasma cfDNA/cfRNA genomic and epigenomic assays, and serum tumor markers were performed. Patients were followed up for 3 years at a 3-month interval. Collect surgically removed colorectal cancer samples to construct PDX models if necessary.

Timeline

• Start date: 2025-05-01
• Primary completion: 2027-11-01
• Completion: 2027-11-01
• First posted: 2025-05-28
• Last updated: 2025-05-28

Locations

1 site across 1 country: China