Ignite Creation Date:
2025-12-24 @ 2:00 PM
Ignite Modification Date:
2026-01-01 @ 7:58 PM
Study NCT ID:
NCT04947995
Status:
UNKNOWN
Last Update Posted:
2021-07-01
First Post:
2021-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi-Omics Noninvasive Inspection of TumOr Risk for Gastric Cancer
Sponsor:
GeneCast Biotechnology Co., Ltd.
Organization:
Study Overview
Official Title:
Validation of a Plasma-based Multiomics Assay and Risk Scoring Model for Screening of Gastric Malignancies
Status:
UNKNOWN
Status Verified Date:
2021-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MONITOR- GAC
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: