Primary Culture of Residual Specimens Obtained From Aspiration of Hepatic Tumor to Predict the Prognosis of the Patients

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Other: not interventional study

• Registration Number: NCT02587793
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief Summary

The aim of this project is to investigate whether the proliferative speeds of cultured cells using our method can be integrated into Barcelona Clinic Liver Cancer (BCLC) staging classification for the possibility of personalized treatment and prediction the outcomes in hepatocellular carcinoma (HCC) patients.

Detailed Description

A total of at least 150 patients will be included and followed for at least one year. The proliferative speeds of cultured cells will be classified into (a) rapid proliferation of HCC cells with or without concomitant rapid proliferation of cancer-associated fibroblasts (CAFs), (b) rapid proliferation of CAFs alone, and (c) slow proliferation three groups. The definition for the rapid proliferation of cultured cells fits at least one of the following two items: (1) growth area of cultured cells at the 15th-28th day \> two times of the growth area measured at the 14th day, or (2) growth area of cultured cells at the 15th-28th day \> 70% growth area of the 25 cm flask. The GraphPad Prism software version 4.03 (GraphPad Software, Inc., La Jolla, CA, USA) is applied for statistical analysis. Influence of the proliferative speeds of cultured cells on survival and cancer progression will be calculated by the logrank test. The statistical significance is defined as P \< 0.05.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-10-24
• Study First Submitted QC: 2015-10-24
• Study First Posted: 2015-10-27
• Primary Completion: 2018-07-31
• Study Completion: 2018-07-31
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-26
• Last Update Posted: 2019-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

Inclusion Criteria

1. Patients are proven to have HCC based on fine-needle aspiration of the tumor.
2. Patient have residual specimens obtained from fine-needle aspiration of the tumor.
3. Patients agree to participate this study after fully explanation.

Exclusion Criteria

1. Patients are not proven to have HCC based on fine-needle aspiration of the tumor.
2. Patient do not have residual specimens obtained from fine-needle aspiration of the tumor.
3. Patients do not agree to participate this study after fully explanation.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Barcelona Clinic Liver Cancer (BCLC) staging	not interventional study	The tumor stages of the patient are classified as BCLC stage 0, A, B, C, or D.

Primary Outcome Measures

Name	Time	Method
survival	one year	Correlation between the proliferative speeds of cultured cells and one year survival of the patients after aspiration of the tumor will be investigated.

Secondary Outcome Measures

Name	Time	Method
cancer progression	one year	Correlation between the proliferative speeds of cultured cells and HCC progression one year after aspiration of the tumor will be investigated.

Trial Locations

Locations (2)

Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan