Hepatocellular Carcinoma
Conditions
Brief summary
Blood samples will be tested to identify circulating tumor DNA and plasma protein levels to potentially improve prediction of long term prognosis and guide treatment options of patients with hepatocellular carcinoma underwent surgical resection.
Interventions
DIAGNOSTIC_TESTctDNA monitoring
The ctDNA level will be measured using tumor-informed (Signatera platform) and tumor-naived (fragmentomes measurement) assay.
DIAGNOSTIC_TESTPlasma proteomic analysis
plasma protein level will be measured via Proximity Extension Assay and LC-MS based proteomic analysis
Sponsors
Shanghai Zhongshan Hospital
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients with a first diagnosis of HCC. * Patients with HCC who are to undergo surgical treatment, with or without neoadjuvant therapy. * Ability to obtain tissue sample for ctDNA analysis and detectable baseline ctDNA level.
Exclusion criteria
* Patients with secondary liver cancer, or intrahepatic cholangiocarcinoma. * Any other concurrent malignancy. * History of organ transplant or hepatic encephalopathy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between ctDNA level and recurrence-free survival (RFS) | 1 years | ctDNA measurements will be made at baseline and 1 months, 3 months, 6 months, 12 months after surgery. RFS will be assessed by standard radiographic imaging. |
| Correlation between specific plasma protein expression level and recurrence-free survival (RFS) | 1 years | plasma proteomic measurements will be made at baseline and 1 months, 3 months, 6 months, 12 months after surgery. RFS will be assessed by standard radiographic imaging. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between tumor mutation numbers and recurrence-free survival (RFS) | 1 years | Patients with available tumor tissues were sequenced to identify their specific tumor variants.The correlation of mutation numbers and RFS will be analysis. |
Countries
China
Contacts
Primary ContactHuichuan Sun
Outcome results
None listed