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NCT05626985
Establishment of a Clinical Diagnostic Model GAMAD for Early-stage HCC Based on Circulating Tumor DNA Methylation
Conditions: Hepatocellular Carcinoma
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Enrollment: 2000
Sponsor: Singlera Genomics Inc.
Summary
Most hepatocellular carcinoma (HCC) cases were at advanced stage when diagnosis established.
This study is intended to establish a clinical diagnostic model GAMAD for early-stage HCC and evaluate the diagnostic efficiency the same time.
This study is a multicenter case control study.
Participants including healthy control,HCC, liver cirrhosis, hepatitis and benign tumor-like lesions are consecutively recruited into the cohort.
All the blood samples are collected before any treatments and will be tested in single center in order to decrease bias.
Eligibility Criteria
Inclusion Criteria:Age above 18Establishing Diagnosis according to the European Association for the Study of Liver(EASL) criteriaHigh risk group of developing HCC including liver cirrhosis and hepatitis under the confirmed diagnosisAble to provide sufficient and qualified blood samples for study testsNo prior or undergoing cancer treatment (local or systematic)Able to provide a written informed consentExclusion Criteria:Obstructive jaundice patientsMedical history of taking warfarinWith other known malignant tumors or multiple primary tumorsPatients with autoimmune diseases, genetic diseases, mental diseases/ disabilities and other diseases considered unsuitable for the study by the investigatorDuring pregnancy or lactationRecipient of blood transfusion within 3 months prior to study blood drawInsufficient qualified blood sample for study test
Source: ClinicalTrials.gov (NCT05626985). StuddyBuddy aggregates publicly available trial information.