Value of Dynamic Monitoring of Early Recurrence of Hepatocellular Carcinoma After Radical Resection Based on CTCS

March 12, 2024 updated by: Zhujiang Hospital

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".

Study Overview

Status

Not yet recruiting

Conditions

Intervention / 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 Type

Observational

Enrollment (Estimated)

82

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

  • Name: Mingxin Pan, Prof.
  • Phone Number: +8618928918216
  • Email: pmxwxy@sohu.com

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Foshan, Guangdong, China
        • The Sixth Affiliated Hospital of South China University of Technology
        • Contact:
          • Weichao Liang, Prof.
          • Phone Number: 13590542927
        • Principal Investigator:
          • Weichao Liang
      • Guangzhou, Guangdong, China
        • Affiliated Cancer Hospital and Institute of Guangzhou Medical University
        • Contact:
          • Yinbing Wu, Prof.
          • Phone Number: 18620007296
        • Principal Investigator:
          • Yinbing Wu
      • Guangzhou, Guangdong, China, 510220
        • Zhujiang Hospital of Southern Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mingxin Pan, Prof.

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patient with hepatocellular carcinoma who can undergo radical surgical resection

Description

Inclusion Criteria:

  1. Male or female patients aged 18-75 years;
  2. Preoperative imaging examination diagnosed hepatocellular carcinoma (BCLC) stage 0 /stage A/stage B, eligible for radical surgery;
  3. ECOG physical status score is 0-1;
  4. Child-Pugh score is 5-6 points (Level A);
  5. Not received any anti-tumor therapy;
  6. Laboratory tests were at normal levels within 7 days before enrollment.

Exclusion Criteria:

  1. Patient can't provide blood samples for CTCs and CTC-DNA testing;
  2. Patient with two or more types of tumors at the same time;
  3. Non-primary liver lesions;
  4. Pregnant or lactating women;
  5. 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;
  6. Patient with serious heart disease;
  7. Other conditions deemed unsuitable for inclusion by the researcher.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient with hepatocellular carcinoma
Patient with hepatocellular carcinoma who can undergo radical resection
Diagnostic test: circulating tumor cells
blood sample and tissue specimen for circulating tumor cell and DNA will be done to patient with hepatocellular carcinoma
Other Names:
  • circulating tumor cell DNA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2-year recurrence-free survival rate
Time Frame: 2 years
percentage of recurrence-free survival 2 years after surgery
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between CTCs status dynamic changes and relapse
Time Frame: 2 years
Correlation between CTCs status dynamic changes and relapse
2 years
Correlation between metastasis，primary tumor and CTCs in blood through NGS and CTC-DNA
Time Frame: 2 years
The subclonal origin of recurrent/metastatic foci derived from CTCs was verified at the molecular level in hepatocellular carcinoma
2 years

Collaborators and Investigators

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

Sponsor

Zhujiang Hospital

Investigators

  • Principal Investigator: Mingxin Pan, Prof., Southern Medical University, China

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 (Estimated)

April 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 12, 2024

First Submitted That Met QC Criteria

March 12, 2024

First Posted (Actual)

March 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-KY-048-01

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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