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

February 26, 2019 updated by: Zu-Yau Lin, Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung Medical University Chung-Ho Memorial Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

208

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 807
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Kaohsiung, Taiwan
        • Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
survival
Time Frame: 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.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cancer progression
Time Frame: one year
Correlation between the proliferative speeds of cultured cells and HCC progression one year after aspiration of the tumor will be investigated.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Investigators

  • Principal Investigator: Zu-Yau Lin, MD, Kaohsiung Medical University Chung-Ho Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

July 31, 2018

Study Completion (Actual)

July 31, 2018

Study Registration Dates

First Submitted

October 24, 2015

First Submitted That Met QC Criteria

October 24, 2015

First Posted (Estimate)

October 27, 2015

Study Record Updates

Last Update Posted (Actual)

February 27, 2019

Last Update Submitted That Met QC Criteria

February 26, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KMUH-IRB-20140182

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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