Auxiliary Diagnosis of Liver Nodules Using cfDNA Whole-genome Signatures
- Conditions
- Focal Liver Lesions
- Interventions
- Other: No interventions
- Registration Number
- NCT05393102
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 400
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Malignant liver nodules cohort No interventions Participants with malignant liver nodules diagnosed by pathological biopsy. Uncertain benign or malignant liver nodules cohort No interventions Participants with liver nodules could not be diagnosed definitely by imaging examination and serum protein markers. Benign liver nodules cohort No interventions Participants with benign liver nodules diagnosed by pathological biopsy or imaging examination.
- Primary Outcome Measures
Name Time Method Specificity of the cfDNA whole-genome signatures based model in liver nodules diagnosis. Enrollment of the first participant up to 18 months Specificity is defined as the proportion of negatively detected participants in all benign liver nodules patients by cfDNA signatures.
Sensitivity of the cfDNA whole-genome signatures based model in liver nodules diagnosis. Enrollment of the first participant up to 18 months Sensitivity is defined as the ratio of positively detected participants in all malignant nodule patients by cfDNA signatures.
- Secondary Outcome Measures
Name Time Method Specificity of the model that composed of cfDNA signatures, imaging examination，serum protein markers and clinical characteristics in liver nodules diagnosis. Through study completion，an average of 18 months Specificity is defined as the proportion of negatively detected participants in all benign liver nodules patients by the model that composed of cfDNA whole-genome signatures, imaging examination，serum protein markers， and clinical characteristics.
Trial Locations
- Locations (3)
Nanfang Hospital, Southern Medical University
🇨🇳Guangzhou, Guangdong, China
Eastern Hepatobiliary Surgery Hospital
🇨🇳Shanghai, Shanghai, China
The 2nd affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China