Ignite Creation Date:
2024-05-06 @ 6:27 PM
Last Modification Date:
2024-10-26 @ 2:48 PM
Study NCT ID:
NCT05668910
Status:
RECRUITING
Last Update Posted:
2022-12-30
First Post:
2022-12-12
Brief Title:
Gastric Cancer Early Detection by Multi-dimensional Analysis of cfDNA
Sponsor:
GeneCast Biotechnology Co Ltd
Organization:
GeneCast Biotechnology Co Ltd
Study Overview
Official Title:
Development and Validation of a Blood-based Assay for Gastric Cancer Early Detection Using Multi-dimensional Analysis of Cell Free DNA Whole Methylome Sequencing-Protocol for an Observational Case-control Study
Status:
RECRUITING
Status Verified Date:
2022-11
Last Known Status:
None
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:
None
Brief Summary:
To facilitate the early gastric cancer diagnosis an assay based on assessing large-scale methylation and fragmentation profiles of the plasma cell free cfDNA will be developed and validated
Detailed Description:
Cancer-related features in cell-free DNA cfDNA fragments have gradually been identified and play essential roles for non-invasive early cancer detection Integrated analysis of several cfDNA features have proven to achieve enhanced detection sensitivity as compared to single feature
This study aims to develop and validate a novel blood-based whole methylome sequencing followed with a multi-dimensional model to analyze several features of cfDNA for GC early detection Specifically blood samples will be prospectively collected before gastroscopy Cases and controls will be randomly divided into a training and a testing dataset at a ratio of 21 Plasma cfDNA will be isolated and extracted followed with a bisulfite-free low-depth whole methylome sequencing A multi-dimensional model named THorough Epigenetic Marker Integration Solution THEMIS including methylation fragmentation and chromosomal copy number alternation will be constructed in the training dataset The performance of the model in differentiating cancer patients from non-cancer controls will then be evaluated in the testing dataset
This study aims to develop and validate a novel blood-based whole methylome sequencing followed with a multi-dimensional model to analyze several features of cfDNA for GC early detection Specifically blood samples will be prospectively collected before gastroscopy Cases and controls will be randomly divided into a training and a testing dataset at a ratio of 21 Plasma cfDNA will be isolated and extracted followed with a bisulfite-free low-depth whole methylome sequencing A multi-dimensional model named THorough Epigenetic Marker Integration Solution THEMIS including methylation fragmentation and chromosomal copy number alternation will be constructed in the training dataset The performance of the model in differentiating cancer patients from non-cancer controls will then be evaluated in the testing dataset
Study Oversight
Has Oversight DMC:
None
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?:
None