Status:

UNKNOWN

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

Lead Sponsor:

Singlera Genomics Inc.

Collaborating Sponsors:

Shanghai Zhongshan Hospital

Conditions:

Hepatocellular Carcinoma

Eligibility:

All Genders

18-80 years

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 systemi...

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...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • 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.

Key Trial Info

Start Date :

December 25 2023

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 1 2025

Estimated Enrollment :

475 Patients enrolled

Trial Details

Trial ID

NCT06178809

Start Date

December 25 2023

End Date

December 1 2025

Last Update

January 3 2024

Active Locations (1)

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Fudan university Zhongshan Hospital

Shanghai, Shanghai Municipality, China, 200032