Clinical Research on Dynamic Monitoring MRD Via Plasma ctDNA After Systemic Therapy of Hepatocellular Carcinoma

Singlera Genomics

Status: Enrolling

Conditions: Hepatocellular Carcinoma

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06178809

KYS-2021002

Details and patient eligibility

About

This study aims to combine biomarker characteristic atlas and ctDNA detection technology to establish a precise standard scheme for minimal residual diagnosis of liver cancer after surgery and systemic treatment.

Full description

This study is a prospective, single-blind, randomized, controlled, single-center study. The patients with liver cancer are recruited after surgery or systemic treatment. Intraoperative cancer and para-cancer tissues of surgical patients are collected, and peripheral blood of all patients after multiple follow-up visits before and after treatment are also collected. The established detection method and model are used to detect blood ctDNA of patients with liver cancer after treatment, and the follow-up data are collected to observe the correlation between the genomic characteristics of plasma at multiple follow-up points after treatment and the recurrence or progression after treatment. The sensitivity and specificity of ctDNA detection method is calculated to predict the risk of relapse or progression after treatment.

Enrollment: 475 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18-80 years old (including 80 years old), gender is not limited;
2. Patients diagnosed with primary HCC;
3. ECOG score ≤1;
4. no previous malignant tumors, including liver cancer;
5. Before blood collection, the patient had not received any treatment related to liver cancer, including surgery, transplantation, radiotherapy, chemotherapy, etc.;
6. Survival period of ≥3 years as initially assessed by researchers;
7. Those who are fully aware of this study and voluntarily sign the informed consent.

Exclusion criteria

1. Patients diagnosed with esophageal cancer, gastric cancer, colorectal cancer, lung cancer, pancreatic cancer, breast cancer and other malignant tumors;
2. Patients who have received major surgical treatment such as blood transfusion or transplantation within 3 months;
3. Participate in other interventional clinical investigators within 3 months;
4. Pregnant or lactating women;
5. Patients with autoimmune diseases, genetic diseases, mental disorders/disabilities, substance abuse and other diseases deemed unsuitable for participation in the study by the researchers;
6. Poor compliance, according to the judgment of the researcher can not complete the study.