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

Sponsor
Zhongnan Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT04688606
Collaborator
(none)
300
1
15.9
18.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Zhongnan Hospital of Wuhan University
Actual Study Start Date :
Jan 22, 2020
Anticipated Primary Completion Date :
May 20, 2021
Anticipated Study Completion Date :
May 20, 2021

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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;

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zhongnan Hospital of Wuhan University Wuhan Hubei China 430071

Sponsors and Collaborators

  • Zhongnan Hospital

Investigators

  • Study Director: Qifa Ye, Wuhan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhongnan Hospital
ClinicalTrials.gov Identifier:
NCT04688606
Other Study ID Numbers:
  • 2020108
First Posted:
Dec 30, 2020
Last Update Posted:
Dec 30, 2020
Last Verified:
Jan 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Zhongnan Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 30, 2020