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

NCT04688606 | Unknown DMC

• 1 other identifier: 2020108
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Circulating Tumor Cell

Keywords

Circulating tumor cells, hepatocellular carcinoma

Outcome Measures

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

  2020.01.20-2021.02.28

Secondary Outcomes (1)

• Circulating tumor cell function detection and verification

  2020.03.01-2021.05.20

Study Arms (1)

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

Circulating tumor cell capture technology DIAGNOSTIC_TEST

CTCBIOPSY® automatic testing platform

Two groups

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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;

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Zhongnan Hospital: lead

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

RECRUITING

MeSH Terms

Conditions

Neoplastic Cells, Circulating; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Qifa Ye

  Wuhan University

  STUDY DIRECTOR

Central Study Contacts

Qifa Ye

CONTACT

+86-02767812988; 190679136@qq.com

Wenjin Liang

CONTACT

+86-02767812988; 190679136@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2020
• First Posted: December 30, 2020
• Study Start: January 22, 2020
• Primary Completion: May 20, 2021
• Study Completion: May 20, 2021
• Last Updated: December 30, 2020

Record last verified: 2020-01

Locations

CN (1)