Image

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

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

Recruiting
18-80 years
All
Phase N/A

Powered by AI

Overview

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.

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

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 details
    Hepatocellular Carcinoma

NCT06178809

Singlera Genomics Inc.

27 January 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.