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

NCT06178809 | Unknown

• 1 other identifier: KYS-2021002
• Study Type: observational
• Target: 475
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

HCC; MRD; ctDNA; Mutation; Methylation

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Singlera Genomics Inc.: lead
• Shanghai Zhongshan Hospital: collaborator

Study Sites (1)

Fudan university Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Jian Zhou, MD

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Zhou, MD

CONTACT

+86 13801914007; zhou.jian@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 21, 2023
• Study Start: December 25, 2023
• Primary Completion: April 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 3, 2024

Record last verified: 2023-12

Locations

CN (1)