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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Kaohsiung Medical University Chung-Ho Memorial Hospital.
Recruitment status was  Recruiting
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: March 6, 2012
Last verified: April 2010
  Purpose

The purposes of this prospective study were to evaluate the successful rate of primary culture of hepatocellular carcinoma cells and cancer-associated fibroblasts from the residual specimens in routine fine-needle aspiration of hepatic tumor and the potential application of this method as an additional tool for personalized treatment of hepatocellular carcinoma patients.


Condition
Hepatocellular Carcinoma

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Kaohsiung Medical University Hospital

Resource links provided by NLM:


Further study details as provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:

Primary Outcome Measures:
  • growth speed of cultured cells [ Time Frame: 28 days after plating of cells ] [ Designated as safety issue: No ]
    correlation the growth speed of cells (reach equal or more than 70% growth area of 25 cm2 culture flask) and TNM tumor staging


Secondary Outcome Measures:
  • TNM tumor staging [ Time Frame: 6 months after plating of cells ] [ Designated as safety issue: No ]
    change in tumor staging

  • survival of patient [ Time Frame: 6 months after plating of cells ] [ Designated as safety issue: No ]
    correlation the growth speed of cultured cells measured at 28 days after plating (reach equal or more than 70% growth area of 25 cm2 culture flask)and cancer-related death of patient within 6 months after plating of cells


Biospecimen Retention:   Samples With DNA

cancer cells and cancer-associated fibroblasts


Estimated Enrollment: 100
Study Start Date: April 2010
Detailed Description:

Fine-needle aspiration (FNA) cytology or biopsy of hepatic tumor is frequently applied in the collection of specimens because it is considered safe, efficacious, accurate and cost effective. Our previous study from small number of patients showed that specimens obtained from FNA had potential to be applied for primary culture of cancer cells. This study was to modified our method for primary culture of both hepatocellular carcinoma cells and cancer-associated fibroblasts in patients with tumor measuring larger than or equal to 3cm. All patients received one session of aspiration for the diagnosis of hepatic tumor. The aspirated specimens were applied for both cytologic and pathologic examinations at first. After then, 10 mL 0.9% NaCl was aspirated by the same needle connected with the same syringe and injected into 15 mL sterilized centrifugation tube. If the tube contained visible specimens, these specimens were sent for primary culture.

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with hepatic tumor measuring larger than or equal to 3 cm underwent fine-needle aspiration of tumor for diagnosis.

Criteria

Inclusion Criteria:

  • patients had residual aspirated specimens for primary culture.

Exclusion Criteria:

  • patients did not have residual aspirated specimens for primary culture.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01549275

Contacts
Contact: Zu Y Lin, MD 886-7-323-4553 linzuyau@yahoo.com.tw

Locations
Taiwan
Kaohsiung Medical University Hospital Recruiting
Kaohsiung, Taiwan, 807
Contact: Zu Y Lin, MD    886-7-323-4553    linzuyau@yahoo.com.tw   
Principal Investigator: Zu Y Lin, MD         
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
Department of Health, Executive Yuan, R.O.C. (Taiwan)
Investigators
Principal Investigator: Zu Y Lin, MD Kaohsiung Medical University
  More Information

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
Last Updated: March 6, 2012
Health Authority: Taiwan: Department of Health
Taiwan: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on July 24, 2014