Trials / Unknown
UnknownNCT05626985
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
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,000 (estimated)
- Sponsor
- Singlera Genomics Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Detailed description
GALAD score including age, sex, PIVKA-II(DCP), Alpha-fetoprotein (AFP) and alpha-fetoprotein L3 (AFP-L3), is a serum biomarker-based panel that can aid in early detection among patients with a high risk for liver cancer. While increasing studies showed the diagnostic accuracy of AFP-L3 was not as good as that of AFP or PIVKA-II, and AFP-L3 was not significant in the multivariable model. Thus, a model with better diagnostic accuracy and more suitable for Chinese patients is needed. Here, based on a multi-locus blood-based assay targeting circulating tumor DNA methylation, we aim to develop a novel diagnostic model--GAMAD (gender, age, methylation, AFP and DCP) and validate its performance among HCC patients and those at high risk of developing HCC,such as liver cirrhosis, hepatitis patients. This is a multicenter, observational, prospective study. After giving fully informed consent, the participants will undergo the regular treatment according to NCCN guidelines.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | GAMAD | Blood samples are tested for tumor markers including PIVKA-II (DCP),AFP, ctDNA methylation and biochemical tests. |
Timeline
- Start date
- 2022-10-19
- Primary completion
- 2024-10-01
- Completion
- 2024-12-01
- First posted
- 2022-11-25
- Last updated
- 2024-04-01
Locations
3 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05626985. Inclusion in this directory is not an endorsement.