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

NCT ID: NCT06178809

Last Updated: 2024-01-03

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 475 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-25
• Study Completion Date: 2025-12-31

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: collaborator

Singlera Genomics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jian Zhou, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Zhongshan Hospital

Locations

Fudan university Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jian Zhou, MD

Role: CONTACT

zhou.jian@zs-hospital.sh.cn

+86 13801914007

Facility Contacts

Jian Zhou, MD

Role: primary

zhou.jian@zs-hospital.sh.cn

+86 13801914007

Other Identifiers

KYS-2021002

Identifier Type: -

Identifier Source: org_study_id