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

NCT ID: NCT02587793

Last Updated: 2019-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

208 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2018-07-31

Brief Summary

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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

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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.

Conditions

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Hepatocellular Carcinoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Barcelona Clinic Liver Cancer (BCLC) staging

The tumor stages of the patient are classified as BCLC stage 0, A, B, C, or D.

not interventional study

Intervention Type OTHER

Interventions

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not interventional study

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zu-Yau Lin

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zu-Yau Lin, MD

Role: PRINCIPAL_INVESTIGATOR

Kaohsiung Medical University Chung-Ho Memorial Hospital

Locations

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Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type RESULT
PMID: 16509865 (View on PubMed)

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.

Reference Type RESULT
PMID: 25087586 (View on PubMed)

Other Identifiers

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KMUH-IRB-20140182

Identifier Type: -

Identifier Source: org_study_id

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