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

Zhongnan Hospital of Wuhan University

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.

Study Overview

• Status: Unknown
• Conditions: Circulating Tumor Cell
• Intervention / Treatment: Diagnostic test: Circulating tumor cell capture technology

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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Qifa Ye; Phone Number: +86-02767812988; Email: 190679136@qq.com
• Study Contact Backup: Name: Wenjin Liang; Phone Number: +86-02767812988; Email: 190679136@qq.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430071
      • Recruiting
      • Zhongnan Hospital of Wuhan University
      • Contact: Qifa Ye; Phone Number: +86-02767812988; Email: 190679136@qq.com
      • Principal Investigator: Qifa Ye, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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;

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Two groups; Initial diagnosis of suspected hepatocellular carcinoma;; patients undergoing liver transplantation, radical resection or ablation of liver cancer	Diagnostic test: Circulating tumor cell capture technology; CTCBIOPSY® automatic testing platform

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Zhongnan Hospital
• Investigators: Study Director: Qifa Ye, Wuhan University

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2020
• Primary Completion (Anticipated): May 20, 2021
• Study Completion (Anticipated): May 20, 2021

Study Registration Dates

• First Submitted: December 24, 2020
• First Submitted That Met QC Criteria: December 24, 2020
• First Posted (Actual): December 30, 2020

Study Record Updates

• Last Update Posted (Actual): December 30, 2020
• Last Update Submitted That Met QC Criteria: December 24, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Circulating tumor cells, hepatocellular carcinoma
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis; Neoplastic Cells, Circulating
• Other Study ID Numbers: 2020108

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No