Auxiliary Diagnosis of Liver Nodules Using cfDNA Whole-genome Signatures

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.

Sex

All

Minimum age

18 Years

Inclusion Criteria:

* 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 Criteria:

* 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.

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