Ignite Creation Date:
2024-05-06 @ 7:08 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05900583
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-06-12
First Post:
2023-05-12
Brief Title:
Efficacy Evaluation and Recurrence Monitoring of Therapy for Esophageal Squamous Cell Carcinoma Based on ctDNA-MRD
Sponsor:
Guangdong Provincial Peoples Hospital
Organization:
Guangdong Provincial Peoples Hospital
Study Overview
Official Title:
Efficacy Evaluation and Recurrence Monitoring of Neoadjuvant Therapy and Adjuvant Therapy for Esophageal Squamous Cell Carcinoma Based on ctDNA-MRD
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-06
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:
This project is focusing on who have locally advanced esophageal squamous cell carcinoma and have undergone neoadjuvant and adjuvant therapy followed by surgical resection The exclusive MRD Minimal residual disease probe consists of an exclusive molecular label formulated according to the individual genome mutation profile and 21 critical tumor driver genes By continuously monitoring each patients ctDNA dynamics changes in ctDNA concentration or ctDNA-MRD negativepositive results will serve as the primary indicators to assess the efficacy and prognosis of patients with esophageal squamous cell carcinoma
Detailed Description:
The goal of this project is to recruit 50 patients who have locally advanced esophageal squamous cell carcinoma and have undergone neoadjuvant and adjuvant therapy followed by surgical resection Initially tumor tissues from all patients will undergo a more comprehensive NGS sequencing process WESPlus than whole-exome sequencing This will provide a complete genomic mutation profile for each patient Subsequently a specific algorithm will be used to accurately select 20 mutation sites as the patients unique molecular label Additionally 21 critical driver genes related to tumors will be combined leading to the creation of an exclusive MRD probe This will enable ultra-high-depth capture sequencing of ctDNA samples from patients at 100000x By continuously monitoring each patients ctDNA dynamics changes in ctDNA concentration or ctDNA-MRD negativepositive results will serve as the primary indicators to assess the efficacy and prognosis of patients with esophageal squamous cell carcinoma
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?:
False
Is an FDA AA801 Violation?:
None