Hepatocellular CarcinomaNCT06317896
Value of Dynamic Monitoring of Early Recurrence of Hepatocellular Carcinoma After Radical Resection Based on CTCS
An observational study of Hepatocellular Carcinoma and Circulating Tumor Cell, run by Zhujiang Hospital at 3 sites in China.
Trial summary
On the basis of previous retrospective studies, the Task Force will further optimize the CTCs longitudinal surveillance model and initially validate the subclonal origin (CTC-DNA) of recurrent/metastatic foci derived from CTCs at the molecular level in hepatocellular carcinoma, prospective clinical trials will be… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma, Circulating Tumor Cell, Recurrence
- What is being tested?
- circulating tumor cells
- How many people
- 82 participants
- Where
- 3 sitesChina
- Study dates
- 1 Apr 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with hepatocellular carcinoma who can undergo radical surgical resection
Who may be able to join
- Male or female patients aged 18-75 years;
- Preoperative imaging examination diagnosed hepatocellular carcinoma (BCLC) stage 0 /stage A/stage B, eligible for radical surgery;
- ECOG physical status score is 0-1;
- Child-Pugh score is 5-6 points (Level A);
- Not received any anti-tumor therapy;
- Laboratory tests were at normal levels within 7 days before enrollment.
Who cannot join
- Patient can't provide blood samples for CTCs and CTC-DNA testing;
- Patient with two or more types of tumors at the same time;
- Non-primary liver lesions;
- Pregnant or lactating women;
- Patient with a history of other malignant tumors within the past 5 years or at the same time, except cured skin basal cell carcinoma, cervical carcinoma in situ and thyroid papillary carcinoma;
- Patient with serious heart disease;
- Other conditions deemed unsuitable for inclusion by the researcher.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
The Sixth Affiliated Hospital of South China University of Technology
Foshan, Guangdong
Weichao Liang, Prof., 13590542927
Weichao Liang
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510220
Mingxin Pan, Prof., +8618928918216, pmxwxy@sohu.com
Zhoubin Feng, 19830551997, Fzbin1001@163.com
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou, Guangdong
Yinbing Wu, Prof., 18620007296
Yinbing Wu
About this study
Official title: Value of Dynamic Monitoring of Early Recurrence of Hepatocellular Carcinoma After Radical Resection Based on CTCS: a Prospective Cohort Study
On the basis of previous retrospective studies, the Task Force will further optimize the CTCs longitudinal surveillance model and initially validate the subclonal origin (CTC-DNA) of recurrent/metastatic foci derived from CTCs at the molecular level in hepatocellular carcinoma, prospective clinical trials will be conducted to further validate the predictive value of the CTCS longitudinal monitoring model in predicting postoperative recurrence of hepatocellular carcinoma, and to verify whether it is earlier than imaging to indicate recurrence, to explore the clinical feasibility of CTCs in guiding postoperative adjuvant therapy of liver cancer, and to provide new ideas for early intervention strategy of liver cancer after operation, to establish a set of standardized clinical scheme of auxiliary treatment for patients with liver cancer after operation for accurate and individualized"Early diagnosis and treatment".
Read the detailed description
The recurrence rate of HCC after radical resection is high. MRD is the root cause of HCC recurrence, and the MRD result is an important basis for auxiliary treatment decision-making after radical resection. On the basis of previous retrospective studies, the Task Force will further optimize the CTCs longitudinal surveillance model and initially validate the subclonal origin (CTC-DNA) of recurrent/metastatic foci derived from CTCs at the molecular level in hepatocellular carcinoma, prospective clinical trials will be conducted to further validate the predictive value of the CTCS longitudinal monitoring model in predicting postoperative recurrence of hepatocellular carcinoma, and to verify whether it is earlier than imaging to indicate recurrence, to explore the clinical feasibility of CTCs in guiding postoperative adjuvant therapy of liver cancer, and to provide new ideas for early intervention strategy of liver cancer after operation, to establish a set of standardized clinical scheme of auxiliary treatment for patients with liver cancer after operation for accurate and individualized"Early diagnosis and treatment", to provide high-quality evidence-based medicine for the clinical practice of preventing recurrence after radical hepatectomy
- Conditions
- Hepatocellular Carcinoma, Circulating Tumor Cell, Recurrence, Surgery
- Being tested
- circulating tumor cells
- Keywords
- Hepatocellular Carcinoma, Circulating Tumor Cell, Recurrence, Dynamic Monitoring
- Medical subject headings
- Carcinoma, Hepatocellular, Neoplastic Cells, Circulating, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
circulating tumor cellsDiagnostic test
Also called circulating tumor cell DNA
blood sample and tissue specimen for circulating tumor cell and DNA will be done to patient with hepatocellular carcinoma
| Study group | Role | What they receive |
|---|---|---|
| Patient with hepatocellular carcinoma | Patient with hepatocellular carcinoma who can undergo radical resection Receives: Diagnostic Test: circulating tumor cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year recurrence-free survival rate
percentage of recurrence-free survival 2 years after surgery
Measured: 2 years
Secondary outcomes (2)
Correlation between CTCs status dynamic changes and relapse
Correlation between CTCs status dynamic changes and relapse
Measured: 2 years
Correlation between metastasis，primary tumor and CTCs in blood through NGS and CTC-DNA
The subclonal origin of recurrent/metastatic foci derived from CTCs was verified at the molecular level in hepatocellular carcinoma
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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.
- More trials run by Zhujiang 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mingxin Pan, Prof., Principal investigator, Southern Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06317896
- Sponsor's protocol ID
- 2024-KY-048-01
- Status last verified
- Mar 2024
- First submitted
- 12 Mar 2024
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Dynamic Monitoring of Early Recurrence of Hepatocellular Carcinoma After Radical Resection Based on CTCS: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06317896
- Acronym / sponsor ID
- 2024-KY-048-01
- Conditions
- Hepatocellular Carcinoma, Circulating Tumor Cell, Recurrence, Surgery
- Keywords
- Hepatocellular Carcinoma, Circulating Tumor Cell, Recurrence, Dynamic Monitoring
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Mar 2024 (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.
On the basis of previous retrospective studies, the Task Force will further optimize the CTCs longitudinal surveillance model and initially validate the subclonal origin (CTC-DNA) of recurrent/metastatic foci derived from CTCs at the molecular level in hepatocellular carcinoma, prospective clinical trials will be conducted to further validate the predictive value of the CTCS longitudinal monitoring model in predicting postoperative recurrence of hepatocellular carcinoma, and to verify whether it is earlier than imaging to indicate recurrence, to explore the clinical feasibility of CTCs in guiding postoperative adjuvant therapy of liver cancer, and to provide new ideas for early intervention strategy of liver cancer after operation, to establish a set of standardized clinical scheme of auxiliary treatment for patients with liver cancer after operation for accurate and individualized"Early diagnosis and treatment".
Detailed description
The recurrence rate of HCC after radical resection is high. MRD is the root cause of HCC recurrence, and the MRD result is an important basis for auxiliary treatment decision-making after radical resection. On the basis of previous retrospective studies, the Task Force will further optimize the CTCs longitudinal surveillance model and initially validate the subclonal origin (CTC-DNA) of recurrent/metastatic foci derived from CTCs at the molecular level in hepatocellular carcinoma, prospective clinical trials will be conducted to further validate the predictive value of the CTCS longitudinal monitoring model in predicting postoperative recurrence of hepatocellular carcinoma, and to verify whether it is earlier than imaging to indicate recurrence, to explore the clinical feasibility of CTCs in guiding postoperative adjuvant therapy of liver cancer, and to provide new ideas for early intervention strategy of liver cancer after operation, to establish a set of standardized clinical scheme of auxiliary treatment for patients with liver cancer after operation for accurate and individualized"Early diagnosis and treatment", to provide high-quality evidence-based medicine for the clinical practice of preventing recurrence after radical hepatectomy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with hepatocellular carcinoma | – | Diagnostic Test: circulating tumor cellsPatient with hepatocellular carcinoma who can undergo radical resection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with hepatocellular carcinoma who can undergo radical surgical resection
Key inclusion criteria (6 listed)
- Male or female patients aged 18-75 years;
- Preoperative imaging examination diagnosed hepatocellular carcinoma (BCLC) stage 0 /stage A/stage B, eligible for radical surgery;
- ECOG physical status score is 0-1;
- Child-Pugh score is 5-6 points (Level A);
- Not received any anti-tumor therapy;
Key exclusion criteria (7 listed)
- Patient can't provide blood samples for CTCs and CTC-DNA testing;
- Patient with two or more types of tumors at the same time;
- Non-primary liver lesions;
- Pregnant or lactating women;
- Patient with a history of other malignant tumors within the past 5 years or at the same time, except cured skin basal cell carcinoma, cervical carcinoma in situ and thyroid papillary carcinoma;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| circulating tumor cellsAlso: circulating tumor cell DNAblood sample and tissue specimen for circulating tumor cell and DNA will be done to patient with hepatocellular carcinoma | Diagnostic test | Patient with hepatocellular carcinoma |
Primary outcome
2-year recurrence-free survival rate
Time frame: 2 years
percentage of recurrence-free survival 2 years after surgery
2 secondary outcomes
Correlation between CTCs status dynamic changes and relapse
Time frame: 2 years
Correlation between metastasis，primary tumor and CTCs in blood through NGS and CTC-DNA
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
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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.
Mingxin Pan, Prof. principal investigator
Southern Medical University, China
3 sites 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 and Circulating Tumor Cell, run by Zhujiang Hospital at 3 sites 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 6 inclusion and 7 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: opening soon, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mingxin Pan, Prof. (+8618928918216, pmxwxy@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year recurrence-free survival rate (time frame: 2 years). 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 19 Mar 2024.