Clinical trial NCT06178809: Clinical Research on Dynamic Monitoring MRD Via Plasma ctDNA After Systemic Therapy of Hepatocellular Carcinoma
Official title: Clinical Research on Dynamic Monitoring MRD Via Plasma ctDNA Predicting Postoperative Recurrence and Progression After Systemic Therapy of Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatocellular Carcinoma
Keywords: HCC
MRD
ctDNA
Mutation
Methylation
Lead sponsor: Singlera Genomics Inc.
Sponsor class: INDUSTRY
Collaborators: name: Shanghai Zhongshan Hospital
First posted: 2023-12-21
Enrollment: 475
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 18-80 years old primary hepatocellular carcinoma patients in Zhongshan hospital, Shanghai, China

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity of plasma ctDNA mutation and methylation model to predict disease-free survival (DFS) or progression-free survival (PFS) in patients with primary hepatocellular carcinoma after treatment
timeFrame: 2 years
measure: The advance time of ctDNA dynamic detection compared with AFP+ imaging in monitoring of primary hepatocellular carcinoma recurrence or progression
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan university Zhongshan Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Jian Zhou, MD
role: PRINCIPAL_INVESTIGATOR
References: