Ignite Creation Date:
2024-05-06 @ 5:41 PM
Last Modification Date:
2024-10-26 @ 2:33 PM
Study NCT ID:
NCT05393102
Status:
UNKNOWN
Last Update Posted:
2022-05-26
First Post:
2022-05-08
Brief Title:
Auxiliary Diagnosis of Liver Nodules Using cfDNA Whole-genome Signatures
Sponsor:
The Second Affiliated Hospital of Chongqing Medical University
Organization:
The Second Affiliated Hospital of Chongqing Medical University
Study Overview
Official Title:
Auxiliary Diagnosis of Liver Nodules Using cfDNA Whole-genome SignatuRes GUDIER an Observational Cohort Trial
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
NOT_YET_RECRUITING
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:
GUIDER
Brief Summary:
As a prospective multi-center study GUIDER will recruit 400 liver nodules participants from different provinces and regions across China Except for cfDNA signatures serum biomarkers histopathological biopsy and enhanced MRI will also be performed The sensitivity and specificity of the cfDNA signature based-model in liver nodules diagnosing will be evaluated
Detailed Description:
Patients with liver nodules will be recruited for 1 year Peripheral blood samples of all participants will be collected after being informed about the study and potential risks CfDNA extraction library construction and whole genome sequencing will be performed A machine learning method will be implemented for cfDNA signatures-based model construction at the end of the study Sensitivity and specificity will be used to evaluate the performance of cfDNA signatures-based model in liver nodules diagnosis
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