Cell-free Methylation MarkersNCT05573217
The Utility of Cell-free DNA Methylation Markers for Hepatocellular Carcinoma
An observational study of Cell-free Methylation Markers, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cell-free Methylation Markers
- How many people
- 180 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2021to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
- Over 20 years old.
- In the case of informed consent, willing to sign the consent form of the subjects.
Who cannot join
- Patients who are weak and unable to cooperate with blood test.
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Taiwan
Kai-Wen Huang, MD, PhD, fangyu0429@gmail.com
About this study
Official title: 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.
- Conditions
- Cell-free Methylation Markers
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate efficacy
Correlation of methylation profiling results and tumor treatment response.
Measured: 3 month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start1 Jul 2021
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cell-free Methylation MarkersStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05573217
- Sponsor's protocol ID
- 202106001RIPB
- Status last verified
- Oct 2022
- First submitted
- 3 Oct 2022
- Last updated
- 10 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Cell-free DNA Methylation Markers for the Response Prediction of Systemic Treatment for Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05573217
- Acronym / sponsor ID
- 202106001RIPB
- Conditions
- Cell-free Methylation Markers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
- Over 20 years old.
- In the case of informed consent, willing to sign the consent form of the subjects.
Key exclusion criteria (2 listed)
- Patients who are weak and unable to cooperate with blood test.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate efficacy
Time frame: 3 month after treatment
Correlation of methylation profiling results and tumor treatment response.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cell-free Methylation Markers, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kai-Wen Huang (+886-23123456 ext. 265915, fangyu0429@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate efficacy (time frame: 3 month after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2022; AzTrials last refreshed its copy on 8 Nov 2026.