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

Clinical Research on Dynamic Monitoring MRD Via Plasma ctDNA Predicting Postoperative Recurrence and Progression After Systemic Therapy of Hepatocellular Carcinoma

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.

Study Overview

• Status: Recruiting
• Conditions: Hepatocellular Carcinoma

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.

• Study Type: Observational
• Enrollment (Estimated): 475

Contacts and Locations

• Study Contact: Name: Jian Zhou, MD; Phone Number: +86 13801914007; Email: zhou.jian@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Fudan University Zhongshan Hospital
      • Contact: Jian Zhou, MD; Phone Number: +86 13801914007; Email: zhou.jian@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

18-80 years old primary hepatocellular carcinoma patients in Zhongshan hospital, Shanghai, China

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The advance time of ctDNA dynamic detection compared with AFP+ imaging in monitoring of primary hepatocellular carcinoma recurrence or progression	Patients with primary hepatocellular carcinoma who underwent hepatectomy or systemic therapy are followed up regularly after treatment. During follow-up, plasma ctDNA test results, traditional tumor marker AFP and imaging evaluation data are collected. Mutations and methylation of plasma ctDNA are detected. All the data is analyzed to explore the advance time of dynamic detection of plasma ctDNA mutation and methylation in monitoring recurrence or progression of primary hepatocellular carcinoma compared with AFP+ imaging monitoring.	6 months
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	Plasma ctDNA mutation and methylation are detected after treatment in patients with primary hepatocellular carcinoma who underwent hepatectomy or systemic therapy. Clinical information of disease-free survival (DFS) or progression-free survival (PFS) is collected to explore the predictive effect of plasma ctDNA mutation and methylation status on the prognosis of primary hepatocellular carcinoma after treatment.	2 years

Collaborators and Investigators

• Sponsor: Singlera Genomics Inc.
• Collaborators: Shanghai Zhongshan Hospital
• Investigators: Principal Investigator: Jian Zhou, MD, Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 25, 2023
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: December 11, 2023
• First Submitted That Met QC Criteria: December 11, 2023
• First Posted (Actual): December 21, 2023

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: January 1, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: HCC; Mutation; ctDNA; MRD; Methylation
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: KYS-2021002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No