Refinement and Validation of a Diagnostic Model (GAMAD) for Early Detection of Hepatocellular Carcinoma
Refinement and Validation of a Comprehensive Clinical Diagnostic Model (GAMAD) for Early Detection of Hepatocellular Carcinoma: A Multicenter, Prospective Study Protocol
Singlera Genomics Inc.
2,000 participants
Oct 19, 2022
OBSERVATIONAL
Conditions
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 prospective 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
Inclusion Criteria6
- Age above 18
- Establishing Diagnosis according to the European Association for the Study of Liver(EASL) criteria
- High risk group of developing HCC including liver cirrhosis and hepatitis under the confirmed diagnosis
- Able to provide sufficient and qualified blood samples for study tests
- No prior or undergoing cancer treatment (local or systematic)
- Able to provide a written informed consent
Exclusion Criteria7
- Obstructive jaundice patients
- Medical history of taking warfarin
- With other known malignant tumors or multiple primary tumors
- Patients with autoimmune diseases, genetic diseases, mental diseases/ disabilities and other diseases considered unsuitable for the study by the investigator
- During pregnancy or lactation
- Recipient of blood transfusion within 3 months prior to study blood draw
- Insufficient qualified blood sample for study test
Interventions
Blood samples are tested for tumor markers including PIVKA-II (DCP),AFP, ctDNA methylation and biochemical tests.
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT05626985