Primary Cell Culture of Hepatic Tumorous Cells From Routine Fine-needle Aspiration

This study has been completed.
Sponsor:
Collaborator:
Department of Health, Executive Yuan, R.O.C. (Taiwan)
Information provided by (Responsible Party):
Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01549275
First received: February 7, 2012
Last updated: September 7, 2015
Last verified: July 2013
Results First Received: July 15, 2013  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Hepatocellular Carcinoma

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
From April 2010 to January 2013 in Cancer Center and Division of Hepatobiliary Medicine, Department of Internal Medicine, Kaohsiung Medical University Hospital

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 114 patients signed the inform consents. However, 9 patients were excluded due to negative cytological and pathologic results of malignancy in 4 patients, adenocarcinoma in 2 patients and fungal contamination during the preparation of the specimens in 3 patients.

Reporting Groups
  Description
AJCC TNM Staging < = IIIA HCC Patients Tumor stage is based on the AJCC (American Joint Committee on Cancer) TNM staging system (2010, 7th edition). 76 patients with JACC TNM staging < = IIIA.
AJCC TNM Staging > = IIIB HCC Patients 29 patients belonged to AJCC TNM staging > = IIIB.

Participant Flow:   Overall Study
    AJCC TNM Staging < = IIIA HCC Patients     AJCC TNM Staging > = IIIB HCC Patients  
STARTED     76     29  
COMPLETED     75     29  
NOT COMPLETED     1     0  
Lost to Follow-up                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
AJCC TNM Staging < = IIIA HCC Patients Tumor stage is based on the AJCC (American Joint Committee on Cancer) TNM staging system (2010, 7th edition)
AJCC TNM Staging > = IIIB HCC Patients Tumor stage is based on the AJCC (American Joint Committee on Cancer) TNM staging system (2010, 7th edition)
Total Total of all reporting groups

Baseline Measures
    AJCC TNM Staging < = IIIA HCC Patients     AJCC TNM Staging > = IIIB HCC Patients     Total  
Number of Participants  
[units: participants]
  76     29     105  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     31     18     49  
>=65 years     45     11     56  
Age  
[units: years]
Mean (Standard Deviation)
  66.4  (12)     59.6  (14)     63.1  (12.7)  
Gender  
[units: participants]
     
Female     14     5     19  
Male     62     24     86  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Correlation Between the Growth Speeds of the Cultured Cells and the AJCC TNM Stage (7th Eds) at Entering of the Study.   [ Time Frame: 28 days after plating of cells ]

2.  Secondary:   Correlation Between the Growth Speeds of Cultured Cells and Worsening of AJCC TNM Stages or HCC Related Death 6 Months After Plating of Cells   [ Time Frame: 6 months after plating of cells ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Zu-Yau LIn
Organization: Kaohsiung Medical University Hospital
phone: 886-7-323-4553
e-mail: linzuyau@yahoo.com.tw


Publications:

Responsible Party: Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT01549275     History of Changes
Other Study ID Numbers: 990043
Study First Received: February 7, 2012
Results First Received: July 15, 2013
Last Updated: September 7, 2015
Health Authority: Taiwan: Department of Health
Taiwan: Institutional Review Board