Auxiliary Diagnosis of Liver Nodules Using cfDNA Whole-genome Signatures

The Second Affiliated Hospital of Chongqing Medical University400 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

400

Conditions

Focal Liver Lesions

Interventions

No interventionsOTHER

No interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (3)

The 2nd affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Eastern Hepatobiliary Surgery Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Sensitivity of the cfDNA whole-genome signatures based model in liver nodules diagnosis.

Sensitivity is defined as the ratio of positively detected participants in all malignant nodule patients by cfDNA signatures.

Time frame: Enrollment of the first participant up to 18 months

Specificity of the cfDNA whole-genome signatures based model in liver nodules diagnosis.

Specificity is defined as the proportion of negatively detected participants in all benign liver nodules patients by cfDNA signatures.

Time frame: Enrollment of the first participant up to 18 months

Secondary Outcomes

Specificity of the model that composed of cfDNA signatures, imaging examination，serum protein markers and clinical characteristics in liver nodules diagnosis.

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.

Time frame: Through study completion，an average of 18 months

Central Contacts

Hong Ren, MD

CONTACT

13983888786 renhong0531@vip.sina.com.cn

Data from ClinicalTrials.gov

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