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

Circulating Tumor Cell Clinical Trial

Official title:

Zhongnan Hospital of Wuhan University

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04688606
• Other study ID #: 2020108
• Status: Recruiting
• Start date: January 22, 2020
• Est. completion date: May 20, 2021

Study information

• Verified date: January 2020
• Source: Zhongnan Hospital
• Contact: Qifa Ye
• Phone: +86-02767812988
• Email: 190679136[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 20, 2021
• Est. primary completion date: May 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Circulating Tumor Cell
• Neoplastic Cells, Circulating

Intervention

Diagnostic Test:
• Circulating tumor cell capture technology
CTCBIOPSY® automatic testing platform

Locations

Country	Name	City	State
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Zhongnan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2020.01.20-2021.02.28
Secondary	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	2020.03.01-2021.05.20