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

Hepatocellular Carcinoma Clinical Trial

Official title:

Kaohsiung Medical University Chung-Ho Memorial Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02587793
• Other study ID #: KMUH-IRB-20140182
• Status: Completed
• Start date: October 2014
• Est. completion date: July 31, 2018

Study information

• Verified date: February 2019
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: July 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Other:
• not interventional study

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Kaohsiung
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

Lin ZY, Chuang WL, Chuang YH, Yu ML, Hsieh MY, Wang LY, Tsai JF. Discordant influence of amphotericin B on epirubicin cytotoxicity in primary hepatic malignant cells collected by a new primary culture technique. J Gastroenterol Hepatol. 2006 Feb;21(2):398 — View Citation

Lin ZY, Wu CC, Chuang YH, Chuang WL. Clinical utility of a simple primary culture method in hepatocellular carcinoma patients. J Gastroenterol Hepatol. 2015 Feb;30(2):352-7. doi: 10.1111/jgh.12693. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival	Correlation between the proliferative speeds of cultured cells and one year survival of the patients after aspiration of the tumor will be investigated.	one year
Secondary	cancer progression	Correlation between the proliferative speeds of cultured cells and HCC progression one year after aspiration of the tumor will be investigated.	one year