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Status unknownNCT04688606Updated Dec 30, 2020

Circulating Tumor Cell Capture for Early Diagnosis and Postoperative Tumor Recurrence Monitoring of Liver Cancer

An observational study in Circulating Tumor Cell, sponsored by Zhongnan Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-30.

Sponsored by Zhongnan Hospital · Observational

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
300
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Through the screening of CTCs in patients with suspected liver cancer and liver tumor resection or liver transplantation, the number of CTCs in the blood of liver cancer patients before and after surgery is monitored, and the clinical application significance of CTCs in liver cancer screening and postoperative recurrence monitoring in liver cancer patients is evaluated.

Read the detailed description
  1. Screen patients with suspected liver cancer Long-term exposure to liver cancer risk factors (hepatitis B carriers, past history of schistosomiasis, long-term diet of Aspergillus food, history of liver cirrhosis, etc.), patients with liver cancer are initially suspected.
  2. Monitor the number of CTCs in the blood of patients with liver cancer before and after surgery Imaging examinations show that liver space is occupied by patients with suspected liver cancer. Use CTCBIOPSY® technology to monitor patients' surgical operations (including interventional therapy, tumor resection, or liver cancer liver transplantation) at different times 1-3 days before, 1 month after surgery, and 6 months after surgery The number of CTCs in peripheral blood.
  3. To evaluate the clinical application significance of CTCs in liver cancer screening and postoperative recurrence monitoring in patients with liver cancer Combined with clinicopathology, tumor marker examination and imaging examination, clinical follow-up and follow-up, analyze the clinical significance of CTCs detection in liver cancer patients, and focus on evaluating the relationship between circulating tumor cells in liver cancer screening and postoperative recurrence, and establish a new The liver cancer prediction model improves the prognosis of liver cancer patients.
02

Conditions studied

  • Circulating Tumor Cell

Keywords

  • Circulating tumor cells, hepatocellular carcinoma
03

In context

Neoplastic Cells, Circulating

240 studies on the registry are indexed under Neoplastic Cells, Circulating; 52 are open to participants now.

This study's planned enrollment of 300 is above the median of 113 across 138 observational studies indexed under Neoplastic Cells, Circulating.

Browse Neoplastic Cells, Circulating studies →

Lead sponsor

Zhongnan Hospital is the lead sponsor of 103 studies on the registry; 48 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
Yes
Sampling method
Probability sample

Study population

  1. Primary diagnosis of suspected hepatocellular carcinoma; or liver cancer patients who have undergone liver transplantation, radical resection or ablation of liver cancer;
  2. Age 18-75 years old;
  3. ASA (risk of anesthesia) score I-II;
  4. The ECOG score is 0-1;

Inclusion criteria

  1. Primary diagnosis of suspected hepatocellular carcinoma; or liver cancer patients who have undergone liver transplantation, radical resection or ablation of liver cancer;
  2. Age 18-75 years old;
  3. ASA (risk of anesthesia) score I-II;
  4. The ECOG score is 0-1;

Exclusion criteria

Exclusion Criteria:

  1. In addition to hepatocellular carcinoma, patients diagnosed with other types of tumors;
  2. Patients with extrahepatic or lymphatic metastasis;
  3. Patients who still have serious complications 4 weeks after surgery;
  4. Patients who cannot provide informed consent;
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • Two groups

    1. Initial diagnosis of suspected hepatocellular carcinoma; 2. patients undergoing liver transplantation, radical resection or ablation of liver cancer

    Diagnostic Test: Circulating tumor cell capture technology

Interventions

  • Diagnostic testCirculating tumor cell capture technology

    CTCBIOPSY® automatic testing platform

06

What researchers measure

Primary outcomes

  1. Clinical detection of circulating tumor cells

    To evaluate the specificity of CTCs for liver cancer screening and the feasibility of early recurrence after interventional therapy, tumor resection or liver transplantation

    Time frame: 2020.01.20-2021.02.28

Secondary outcomes

  1. Circulating tumor cell function detection and verification

    Analyze the correlation between circulating tumor cells and clinical prognosis after liver cancer surgery and further mechanism exploration

    Time frame: 2020.03.01-2021.05.20

07

Study locations

1 of 1 sites recruiting
  • Zhongnan Hospital of Wuhan University
    Wuhan, Hubei 430071, China
    • Qifa Ye · Contact · 190679136@qq.com · +86-02767812988
    • Qifa Ye, MD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04688606
Lead sponsor
Zhongnan Hospital
Responsible party
Sponsor
First posted
Dec 30, 2020
Start date
Jan 22, 2020
Primary completion
May 20, 2021 (estimated)
Completion
May 20, 2021 (estimated)
Last update
Dec 30, 2020

Study contacts

Qifa Ye
Contact
190679136@qq.com
+86-02767812988
Wenjin Liang
Contact
190679136@qq.com
+86-02767812988
Qifa Ye
study director · Wuhan University

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 status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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