NCT04947995

Multi-Omics Noninvasive Inspection of TumOr Risk for Gastric Cancer

Validation of a Plasma-based Multiomics Assay and Risk Scoring Model for Screening of Gastric Malignancies

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 450 (estimated)
• Sponsor: GeneCast Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 40 Years – 88 Years
• Healthy volunteers: Accepted

Summary

This is a prospective, case-control study intended to develop and validate a blood-based multi-omics assay and computational model for early detection of gastric cancer. Approximately 450 subjects who receive esophageogastroscopy (EGD) will be enrolled and assigned to three arms including gastric cancer, precancerous lesion, and healthy control based on the diagnosis of EGD and histological results. Cell free DNA will be extracted from peripheral blood of all participants and assayed by next-generation sequencing for biomarkers including somatic mutation, methylation, and chromosome instability signals. In the first stage a multi-omics models will be developed for classification between malignancy group and control groups, and between precancerous group and healthy control. Sensitivity and specificity of the model will be evaluated in an independent validation group in the second stage.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DEVICE	ctDNA multi-omics test	The ctDNA multi-omics test for gastric cancer will be built based on low-pass WGS, methylation, and target region sequencing.

Timeline

• Start date: 2021-06-15
• Primary completion: 2023-06-15
• Completion: 2023-06-15
• First posted: 2021-07-01
• Last updated: 2021-07-01

Locations

1 site across 1 country: China