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Not yet recruitingNCT06317896Updated Mar 19, 2024

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

An observational study in Hepatocellular Carcinoma, Circulating Tumor Cell and Recurrence, sponsored by Zhujiang Hospital. Not yet recruiting at 3 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-03-19.

Sponsored by Zhujiang Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
82
Ages
18 Years to 75 Years
Sex
All
01

Study 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 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

02

Conditions studied

  • Hepatocellular Carcinoma
  • Circulating Tumor Cell
  • Recurrence
  • Surgery

Keywords

  • Hepatocellular Carcinoma
  • Circulating Tumor Cell
  • Recurrence
  • Dynamic Monitoring
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patient with hepatocellular carcinoma who can undergo radical surgical resection

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

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
82 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patient with hepatocellular carcinoma

    Patient with hepatocellular carcinoma who can undergo radical resection

    Diagnostic Test: circulating tumor cells

Interventions

  • Diagnostic testcirculating tumor cells

    blood sample and tissue specimen for circulating tumor cell and DNA will be done to patient with hepatocellular carcinoma

    Also known as: circulating tumor cell DNA

05

What researchers measure

Primary outcomes

  1. 2-year recurrence-free survival rate

    percentage of recurrence-free survival 2 years after surgery

    Time frame: 2 years

Secondary outcomes

  1. Correlation between CTCs status dynamic changes and relapse

    Correlation between CTCs status dynamic changes and relapse

    Time frame: 2 years

  2. 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

    Time frame: 2 years

06

Study locations

3 sites
  • The Sixth Affiliated Hospital of South China University of Technology
    Foshan, Guangdong, China
    • Weichao Liang, Prof. · Contact · 13590542927
    • Weichao Liang · Principal investigator
  • Zhujiang Hospital of Southern Medical University
    Guangzhou, Guangdong 510220, China
    • Mingxin Pan, Prof. · Contact · pmxwxy@sohu.com · +8618928918216
    • Zhoubin Feng · Contact · Fzbin1001@163.com · 19830551997
    • Mingxin Pan, Prof. · Principal investigator
  • Affiliated Cancer Hospital and Institute of Guangzhou Medical University
    Guangzhou, Guangdong, China
    • Yinbing Wu, Prof. · Contact · 18620007296
    • Yinbing Wu · Principal investigator
07

Registry details

Key details

Study ID
NCT06317896
Lead sponsor
Zhujiang Hospital
Responsible party
Sponsor
First posted
Mar 19, 2024
Start date
Apr 1, 2024 (estimated)
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Mar 19, 2024

Study contacts

Mingxin Pan, Prof.
Contact
pmxwxy@sohu.com
+8618928918216
Zhoubin Feng
Contact
Fzbin1001@163.com
19830551997
Mingxin Pan, Prof.
principal investigator · Southern Medical University, China

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
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