Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06653062
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Circulating Tumor Mitochondrial DNA ct-mtDNA As a Biomarker for Resected Hepatocellular Carcinoma Recurrence Surveillance
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of Circulating Tumor Mitochondrial DNA ct-mtDNA As a Biomarker for Minimal Residual Disease MRD Assessment and Recurrence Monitoring in Postoperative Hepatocellular Carcinoma HCC
Status:
NOT_YET_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:
CCGLC-015
Brief Summary:
This is a prospective observational single-center study The purpose of this study is to evaluate the efficacy of circulating tumor mitochondrial DNA ct-mtDNA in plasma as a biomarker for minimal residual disease MRD assessment and recurrence monitoring in patients with resectable hepatocellular carcinoma
Detailed Description:
Hepatocellular carcinoma HCC is a leading cause of cancer-related mortality worldwide with a significant proportion of cases occurring in China Despite advancements in treatment the prognosis for HCC remains poor due to late diagnosis and high recurrence rates Minimal Residual Disease MRD refers to the presence of residual cancer cells after treatment which can lead to tumor recurrence The primary objective of this study is to evaluate the effectiveness of plasma tumor mitochondrial mutations as a biomarker for MRD assessment and recurrence monitoring in patients with resectable HCC The study hypothesizes that the presence and dynamics of tumor mitochondrial mutations in plasma are associated with the risk of recurrence and overall survival in HCC patients This is a prospective observational single-center study conducted by the Chinese Cooperative Group of Liver Cancer CCGLC under the auspices of the Chinese Chapter of International Hepato-Pancreato Biliary Association The study will involve the collection and analysis of plasma samples from patients with HCC to detect ct-mtDNA mutations before and after surgery The primary clinical endpoint is the impact of MRD status on progression-free survival PFS Secondary endpoints include the influence of surgery on MRD markers the correlation between postoperative residual tumor molecular burden and PFS and the ability of MRD detection to predict recurrence earlier than traditional tumor markers or imaging methods This study seeks to contribute to the field of HCC management by providing a more precise and personalized approach to postoperative MRD assessment and recurrence monitoring The findings have the potential to improve long-term treatment outcomes and quality of life for patients with HCC
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