Status:
UNKNOWN
Auxiliary Diagnosis of Liver Nodules Using cfDNA Whole-genome Signatures
Lead Sponsor:
The Second Affiliated Hospital of Chongqing Medical University
Collaborating Sponsors:
Eastern Hepatobiliary Surgery Hospital
Nanfang Hospital, Southern Medical University
Conditions:
Focal Liver Lesions
Eligibility:
All Genders
18+ years
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, histopatholog...
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, lib...
Eligibility Criteria
Inclusion
- Eighteen years or elder；
- Participants underwent enhanced MRI for the evaluation of liver nodules ≤5 cm；
- Participants whose platelet count ≥ 50×109/L, prothrombin activity (PTA) ≥ 60%；
- Participants who are willing and able to perform hepatectomy or tissure biopsy.
Exclusion
- Participants with different enhancement mode liver nodules that detected by enhanced MRI and without CEUS confirmation；
- Diagnosis of malignant tumors before recruitment；
- Anti-tumor therapy before recruitment ；
- HIV infection；
- Pregnancy；
- Allogenic blood transfusion or cell therapy within 14 days before peripheral blood samples collection;
- Participants with hepatic encephalopathy, hemangioma, ascites, gastrointestinal bleeding, jaundice, liver failure, congestive heart failure, or any other serious diseases that causing organ damage.
- Participants with any other factors that may leading to termination of the study.
Key Trial Info
Start Date :
May 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2023
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT05393102
Start Date
May 1 2022
End Date
October 1 2023
Last Update
May 26 2022
Active Locations (3)
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1
The 2nd affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400010
2
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510515
3
Eastern Hepatobiliary Surgery Hospital
Shanghai, Shanghai Municipality, China, 200438