The Utility of Cell-free DNA Methylation Markers for Hepatocellular Carcinoma

October 6, 2022 updated by: National Taiwan University Hospital

The Utility of Cell-free DNA Methylation Markers for the Response Prediction of Systemic Treatment for Hepatocellular Carcinoma

The subjects of this study were patients with liver cancer diagnosed by physicians according to AASLD clinical criteria or pathological biopsy.

Those who plan to receive systemic drug treatment for liver cancer in National Taiwan University Hospital include Nexavar, Lenvatinib, Avastin, Tecentriq, Strivarga, Cabometyx, Cyramza, Nivolunab, Pembrolizumab, and Yervoy. Weak and uncooperative patients were excluded from blood tests, which were performed with full informed consent for relevant tumor markers (AFP ,PIVKA-II and methylation analysis). The data are then counted and compared.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan, Taiwan
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients diagnosed with liver cancer by AASLD clinical criteria or pathological slides Patients planning to receive systemic drug therapy for liver cancer at National Taiwan University Hospital include Nexavar, Lenvatinib, Avastin, Tecentriq, Strivarga, Cabometyx, Cyramza, Nivolunab, Pembrolizumab, and Yevoy.

Description

Inclusion Criteria:

  1. Patients diagnosed with liver cancer by AASLD clinical criteria or pathological slides Patients planning to receive systemic drug therapy for liver cancer at National Taiwan University Hospital include Nexavar, Lenvatinib, Avastin, Tecentriq, Strivarga, Cabometyx, Cyramza, Nivolunab, Pembrolizumab, and Yevoy.
  2. Over 20 years old.
  3. In the case of informed consent, willing to sign the consent form of the subjects.

Exclusion Criteria:

  1. Patients who are weak and unable to cooperate with blood test.
  2. Kidney dysfunction, serum creatinine greater than 1.5 x UNL (normal value) and no hemodialysis treatment, who are judged to be unwell for computed tomography or MRI contrast agent injection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate efficacy
Time Frame: 3 month after treatment
Correlation of methylation profiling results and tumor treatment response.
3 month after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

October 3, 2022

First Submitted That Met QC Criteria

October 6, 2022

First Posted (Actual)

October 10, 2022

Study Record Updates

Last Update Posted (Actual)

October 10, 2022

Last Update Submitted That Met QC Criteria

October 6, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202106001RIPB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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