Clinical trial NCT02587793: Primary Culture of Residual Specimens Obtained From Aspiration of Hepatic Tumor to Predict the Prognosis of the Patients
Official title: Kaohsiung Medical University Chung-Ho Memorial Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular Carcinoma
primary culture
fine-needle aspiration
cancer-associated fibroblast
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2015-10-27
Enrollment: 208
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are proven to have HCC based on fine-needle aspiration of the tumor and also have residual specimens for culture are included.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: survival
timeFrame: one year
Secondary outcomes:
measure: cancer progression
timeFrame: one year
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Kaohsiung Medical University Chung-Ho Memorial Hospital
name: Zu-Yau Lin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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):398-405. doi: 10.1111/j.1440-1746.2005.04026.x.
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.