Hepatocellular CarcinomaNCT06178809
Clinical Research on Dynamic Monitoring MRD Via Plasma ctDNA After Systemic Therapy of Hepatocellular Carcinoma
An observational study of Hepatocellular Carcinoma, run by Singlera Genomics Inc. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma
- How many people
- 475 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2023to Dec 2025
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 18-80 years old primary hepatocellular carcinoma patients in Zhongshan hospital, Shanghai, China
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan university Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Jian Zhou, MD, +86 13801914007, zhou.jian@zs-hospital.sh.cn
About this study
Official title: Clinical Research on Dynamic Monitoring MRD Via Plasma ctDNA Predicting Postoperative Recurrence and Progression After Systemic Therapy of Hepatocellular Carcinoma
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.
Read the 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-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.
- Conditions
- Hepatocellular Carcinoma
- Keywords
- HCC, MRD, ctDNA, Mutation, Methylation
- Medical subject headings
- Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2023
- Study start25 Dec 2023
- Primary completionApr 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 475 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singlera Genomics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Zhongshan Hospital
- Responsible party
- Sponsor
- Investigators
- Jian Zhou, MD, Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06178809
- Sponsor's protocol ID
- KYS-2021002
- Status last verified
- Dec 2023
- First submitted
- 11 Dec 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research on Dynamic Monitoring MRD Via Plasma ctDNA Predicting Postoperative Recurrence and Progression After Systemic Therapy of Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT06178809
- Acronym / sponsor ID
- KYS-2021002
- Conditions
- Hepatocellular Carcinoma
- Keywords
- HCC, MRD, ctDNA, Mutation, Methylation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 475 participants (estimated)
- Lead sponsor
- Singlera Genomics Inc.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Zhongshan Hospital
- Study start
- 25 Dec 2023 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 21 Dec 2023 (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.
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.
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-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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 18-80 years old primary hepatocellular carcinoma patients in Zhongshan hospital, Shanghai, China
Key inclusion criteria (7 listed)
- 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.;
Key exclusion criteria (6 listed)
- 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;
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
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
Time frame: 2 years
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.
The advance time of ctDNA dynamic detection compared with AFP+ imaging in monitoring of primary hepatocellular carcinoma recurrence or progression
Time frame: 6 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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.
Jian Zhou, MD principal investigator
Shanghai Zhongshan Hospital
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 Hepatocellular Carcinoma, run by Singlera Genomics Inc. at 1 site in China.
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 7 inclusion and 6 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 3 Jan 2024. 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 China. 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 Jian Zhou, MD (+86 13801914007, zhou.jian@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 2 years). The study lists 2 primary outcomes in all. 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 3 Jan 2024.