Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06342414
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-03-26
Brief Title:
An Exosome-Based Liquid Biopsy for the Differential Diagnosis of Primary Liver Cancer
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
An Exosome-Based Liquid Biopsy for the Differential Diagnosis of Primary Liver Cancer
Status:
RECRUITING
Status Verified Date:
2024-04
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:
ELUCIDATE
Brief Summary:
It is sometimes difficult to precisely understand whether a primary liver cancer is a hepatocellular carcinoma or a cholangiocarcinoma The researchers will develop and validate a liquid biopsy based on exosomal content analysis and powered by machine learning to help clinicians differentiate these two cancers before surgery
Detailed Description:
Primary liver cancers PLCs encompass a diverse group of malignancies originating from the liver collectively ranking as the third leading cause of cancer-related mortality worldwide in 2020 Among PLCs intrahepatic cholangiocarcinoma ICC and hepatocellular carcinoma HCC represent the most predominant subtypes Despite their collective grouping as PLCs ICC and HCC patients exhibit distinct etiologies pathologies and clinical characteristics necessitating different treatment approaches Accurate differentiation between ICC and HCC is paramount to optimize patient outcomes and guide personalized treatment decisions However a definitive diagnosis is often obtained only after the pathological review of the resected neoplastic tissue which requires invasive tumor sampling and poses risks of complications such as hemorrhage and tumor cell seeding Consequently there is a pressing clinical need to develop noninvasive diagnostic approaches to achieve an accurate differential diagnosis for patients with these distinct forms of PLCs
This study involves the development and validation of a liquid biopsy assessing circulating exosomal microRNAs exo-miRNA for indirect sampling of tumor tissue in the bloodstream The researchers intend to harness machine learning and bioinformatics to create a cost-efficient non-invasive clinic-friendly assay with high sensitivity and specificity aiding the differential diagnosis between ICC and HCC
The researchers intend to do so in three phases
1 To perform comprehensive small RNA-Seq from exo-miRNA from patients with ICC and HCC
2 To develop and train a differential diagnosis panel based on advanced machine-learning models to obtain a final differential diagnosis biomarker
3 To validate the findings in an independent cohort of ICC and HCC
In summary this proposal promises to improve patient care and help clinicians perform a more reliable differential diagnosis between ICC and HCC in patients with primary liver cancer
This study involves the development and validation of a liquid biopsy assessing circulating exosomal microRNAs exo-miRNA for indirect sampling of tumor tissue in the bloodstream The researchers intend to harness machine learning and bioinformatics to create a cost-efficient non-invasive clinic-friendly assay with high sensitivity and specificity aiding the differential diagnosis between ICC and HCC
The researchers intend to do so in three phases
1 To perform comprehensive small RNA-Seq from exo-miRNA from patients with ICC and HCC
2 To develop and train a differential diagnosis panel based on advanced machine-learning models to obtain a final differential diagnosis biomarker
3 To validate the findings in an independent cohort of ICC and HCC
In summary this proposal promises to improve patient care and help clinicians perform a more reliable differential diagnosis between ICC and HCC in patients with primary liver cancer
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