Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06654622
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-21
Brief Title:
Exosome-based Detection of Molecular Residual Disease in Stage II-III Colorectal Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Exosome-Based Liquid Biopsy Assay to Detect Molecular Residual Disease for the Identification of High-Risk Patients with Stage II-III Colorectal Cancer
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to establish an exosome-based liquid biopsy signature to detect molecular residual disease MRD in stage II-III colorectal cancer CRC patients Identifying patients with MRD after surgery is crucial for selecting appropriate candidates for adjuvant chemotherapy ACT allowing for more personalized treatment approaches and potentially improving patient outcomes
Detailed Description:
The current standard for treating stage II-III colorectal cancer involves surgical resection often followed by adjuvant chemotherapy ACT for high-risk patients However identifying patients who would benefit most from ACT remains challenging Molecular residual disease MRD in these patients is a critical factor in determining the likelihood of recurrence This study aims to develop an exosome-based liquid biopsy assay using circulating exosomal microRNAs exo-miRNAs to predict the presence of MRD in postoperative patients By analyzing exo-miRNAs from blood samples collected after surgery the goal is to identify high-risk patients who may benefit from ACT while sparing low-risk patients from unnecessary treatment A risk-stratification model termed the exosome-based molecular residual disease prediction for adjuvant chemotherapy induction EMRATI score will be developed to improve ACT decision-making and enhance clinical outcomes for stage II-III CRC patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None