Circulating Tumor Cell Detection in Hepatocellular Carcinoma

NCT ID: NCT05297955

Last Updated: 2022-04-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 458 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-11-01
• Study Completion Date: 2022-03-15

Brief Summary

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.

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.

Conditions

Circulating Tumor Cell

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tongji Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chen Xiaoping

Chair of surgery department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaoping Chen

Role: STUDY_CHAIR

Tongji Hospital

Locations

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Countries

China

Other Identifiers

TJ-IRB20211242

Identifier Type: -

Identifier Source: org_study_id