ClinicalTrials.gg
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

In context

Carcinoma, Hepatocellular

3,648 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,061 are open to participants now.

This study's planned enrollment of 82 is below the median of 200 across 850 observational studies indexed under Carcinoma, Hepatocellular.

Browse Carcinoma, Hepatocellular studies →

Lead sponsor

Zhujiang Hospital is the lead sponsor of 202 studies on the registry; 96 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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. physical status score is 0-1;
  4. 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

05

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

06

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

07

Study locations

3 sites
  • The Sixth Affiliated Hospital of South China University of Technology
    Foshan, Guangdong, China
    • Weichao Liang, Prof. · Contact13590542927
    • Weichao Liang · Principal investigator
  • Zhujiang Hospital of Southern Medical University
    Guangzhou, Guangdong 510220, China
    • Mingxin Pan, Prof. · Contactpmxwxy@sohu.com · +8618928918216
    • Zhoubin Feng · ContactFzbin1001@163.com · 19830551997
    • Mingxin Pan, Prof. · Principal investigator
  • Affiliated Cancer Hospital and Institute of Guangzhou Medical University
    Guangzhou, Guangdong, China
    • Yinbing Wu, Prof. · Contact18620007296
    • Yinbing Wu · Principal investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Apr 2024; primary completion for Dec 2026, 32 months later.

Of 302 non-industry observational studies under Carcinoma, Hepatocellular, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 114. This study's planned 32 months is below that.

Counting every sponsor, half of 351 studies reached it within 51 months; a quarter within 32 and three quarters within 108.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 12, 2024
First posted
Mar 19, 2024
StartEst.
Apr 1, 2024
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Mar 19, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

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
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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