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

• Conditions: Circulating Tumor Cell
• Interventions: Diagnostic Test: Circulating tumor cell capture technology

• Registration Number: NCT04688606
• Lead Sponsor: Zhongnan Hospital

Brief 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.

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.

Study Timeline

• Status Verified: 2020-01
• Study Start: 2020-01-22
• Study First Submitted: 2020-12-24
• Study First Submitted QC: 2020-12-24
• Last Update Submitted: 2020-12-24
• Study First Posted: 2020-12-30
• Last Update Posted: 2020-12-30
• Primary Completion: 2021-05-20
• Study Completion: 2021-05-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

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;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Two groups	Circulating tumor cell capture technology	1. Initial diagnosis of suspected hepatocellular carcinoma; 2. patients undergoing liver transplantation, radical resection or ablation of liver cancer

Primary Outcome Measures

Name	Time	Method
Clinical detection of circulating tumor cells	2020.01.20-2021.02.28	To evaluate the specificity of CTCs for liver cancer screening and the feasibility of early recurrence after interventional therapy, tumor resection or liver transplantation

Secondary Outcome Measures

Name	Time	Method
Circulating tumor cell function detection and verification	2020.03.01-2021.05.20	Analyze the correlation between circulating tumor cells and clinical prognosis after liver cancer surgery and further mechanism exploration

Trial Locations

Locations (1)

Zhongnan Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China