NCT06456281

Multi-omics Model for Pancreatic Cancer Screening Using cfDNA

Development and Validation of Multi-omics Model for Screening of Pancreatic Cancer Using cfDNA

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 480 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This is a prospective case-control study, aiming at developing a cell free DNA (cfDNA) multi-omics precise diagnostic model for screening of pancreatic cancer.

Detailed description

Peripheral blood samples from participants with new diagnosis of pancreatic cancers, precancerous lesions and healthy individuals will be collected to characterize the cancer-specific signatures by low-pass whole-genome sequencing and target methylation sequencing using cfDNA. An ensemble multi-omics model will be trained aided by machine learning algorithm and validated in test set. The performance of this multi-omics model distinguishing pancreatic cancer from non-cancer will be evaluated.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	A noninvasive cfDNA multi-omics assay	Peripheral venous blood samples will be collected from pancreatic cancer patients, individuals with precancerous lesions, and healthy controls. Subsequently, cfDNA will be extracted and subjected to low-pass whole genome sequencing (LP-WGS) and hybrid capture-based targeted methylation sequencing (TMS).

Timeline

• Start date: 2024-06-28
• Primary completion: 2025-03-30
• Completion: 2025-12-30
• First posted: 2024-06-13
• Last updated: 2024-07-01

Locations

1 site across 1 country: China