Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06342427
Status:
COMPLETED
Last Update Posted:
2024-07-08
First Post:
2024-03-26
Brief Title:
Stomach Cancer Exosome-based Detection
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
Early Detection of Stomach Cancer With a Liquid Biopsy Based on Exosomal Micro-RNA
Status:
COMPLETED
Status Verified Date:
2024-07
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:
DESTINEX
Brief Summary:
Gastric cancer continues to have a poor prognosis primarily due to the inability to detect it in its early stages This study will develop and validate a blood assay to facilitate the non-invasive detection of gastric cancer
Detailed Description:
Gastric cancer continues to have a poor prognosis primarily due to the inability to detect it in its early stages Because conventional endoscopy is invasive and costly gastric cancer is currently not considered to be screenable at a population level However if one could find less invasive and cheaper tools that accurately detect gastric cancer in its early stages it could make a significant difference Accurate biomarkers could help identify patients with gastric cancer before it becomes incurable
This study aims to develop a non-invasive test to detect gastric cancer early It consists of four phases
1 Discovering potential biomarkers with a comprehensive and genome-wide transcriptomic sequencing analysis that will involve gastric cancer tissue normal tissue and serum samples from patients with gastric cancer as well as samples from people without the disease
2 Using machine learning to develop a combination signature of cell-free cf and exosomal exo-miRNA in serum specimens from a training cohort
3 A validation of this signature in an independent cohort to confirm its accuracy
4 An evaluation of the temporal trend of this signature in paired samples collected pre-surgery and post-surgery to investigate their potential and specificity as indicators of minimal residual disease
In summary this study aims to develop a highly accurate and cost-effective blood test for detecting gastric cancer early Success could lead to significant improvements in clinical practice by catching cancer when it is most treatable By combining different genetic markers cell-free microRNA and exosomal microRNA for accuracy this study has the potential to reduce gastric cancer deaths and could lead to new screening methods in the future
This study aims to develop a non-invasive test to detect gastric cancer early It consists of four phases
1 Discovering potential biomarkers with a comprehensive and genome-wide transcriptomic sequencing analysis that will involve gastric cancer tissue normal tissue and serum samples from patients with gastric cancer as well as samples from people without the disease
2 Using machine learning to develop a combination signature of cell-free cf and exosomal exo-miRNA in serum specimens from a training cohort
3 A validation of this signature in an independent cohort to confirm its accuracy
4 An evaluation of the temporal trend of this signature in paired samples collected pre-surgery and post-surgery to investigate their potential and specificity as indicators of minimal residual disease
In summary this study aims to develop a highly accurate and cost-effective blood test for detecting gastric cancer early Success could lead to significant improvements in clinical practice by catching cancer when it is most treatable By combining different genetic markers cell-free microRNA and exosomal microRNA for accuracy this study has the potential to reduce gastric cancer deaths and could lead to new screening methods in the future
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