Circulating Tumor Cell Detection in Hepatocellular Carcinoma

A Retrospective Study of Data Related to Circulating Tumor Cell Detection in Hepatocellular Carcinoma

The investigators examined circulating tumor cells (CTC) in the perioperative peripheral blood of hundreds of HCC patients undergoing liver cancer surgery using CellSearch technology between 2013 and 2016. Although the investigators have done a preliminary study of the above data and published some results, the previous study was only a basic analysis. Now the investigators plan to carry out further in-depth analysis of these data, including hospitalization data, follow-up results, surgical tumors and blood specimens, and make full use of biostatistics, molecular biology, pathology and other related techniques to elucidate the association between the levels of CTC or CTC clusters and patients' disease during the perioperative period, and to explore the molecular basis of CTC production in hepatocellular carcinoma.

Study Overview

• Status: Completed
• Conditions: Circulating Tumor Cell

Detailed Description

From 2013 to 2016, CellSearch technology was used to detect the number of circulating tumor cells (CTC) in peripheral blood of hundreds of HCC patients undergoing liver cancer surgery during perioperative period. The analysis results confirmed that the level of CTC before and after surgery were significantly correlated with overall survival (OS) and disease-free survival (DFS) of patients. CTC level changed before and after surgery, but there was no statistical difference. Preoperative CTC was more correlated with patients' disease-related clinical parameters, while postoperative CTC was an independent prognostic indicator of patients after surgery. In addition, the investigators' study found that CTC clusters level can be a new marker of tumor progression in HCC patients.

Based on the above data, the investigators will perform retrospective analysis to compare the relationship between CTC level and clinical indicators of HCC patients. Participants were divided into groups according to pathological type, differentiation degree, clinical stage, invasion degree, recurrence and metastasis of tumors. Combined with immunohistochemistry and quantitative PCR results, the correlation of CTC in tumor genesis, pathological model, degree of differentiation, tumor stage, invasion, metastasis and expression of other tumor markers was studied.

• Study Type: Observational
• Enrollment (Actual): 458

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Perioperative patients with hepatocellular carcinoma who underwent CTC detection of peripheral blood

Description

Inclusion Criteria:

• The pathological diagnosis was primary liver cancer.
• Undergoing radical surgical treatment
• No preoperative antitumor therapy was received
• Between 18 and 80 years old

Exclusion Criteria:

• With distal metastasis
• With other tumors
• Perioperative death
• Recurrence within one month after surgery
• Lost contact before the first follow-up

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
The number of CTC in HCC patient great than or equal to two; According to the cutoff of CTC, the number of CTC in HCC patient great than or equal to two
The number of CTC in HCC patient less than two; According to the cutoff of CTC,the number of CTC in HCC patient less than two

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Data analysis of relationship between CTC and pathological indicators of hepatocellular carcinoma	The previous CTC detection data of 458 cases was collected. To compare the relationship between CTC level of perioperative peripheral blood and clinical indexes of HCC patients, the main statistical analysis were one-way ANOVA, Student's T test and Multivariable Cox regression.	2022.03.15

Collaborators and Investigators

• Sponsor: Tongji Hospital
• Investigators: Study Chair: Xiaoping Chen, Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2013
• Primary Completion (Actual): June 30, 2016
• Study Completion (Actual): March 15, 2022

Study Registration Dates

• First Submitted: March 17, 2022
• First Submitted That Met QC Criteria: March 17, 2022
• First Posted (Actual): March 28, 2022

Study Record Updates

• Last Update Posted (Actual): April 6, 2022
• Last Update Submitted That Met QC Criteria: March 27, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Neoplastic Processes; Neoplasm Metastasis; Carcinoma, Hepatocellular; Neoplastic Cells, Circulating
• Other Study ID Numbers: TJ-IRB20211242

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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