- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01549275
Primary Cell Culture of Hepatic Tumorous Cells From Routine Fine-needle Aspiration
September 7, 2015 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung Medical University Hospital
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
105
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
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Kaohsiung, Taiwan, 807
- Kaohsiung Medical University Hospital
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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
20 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
Inclusion Criteria:
- patients had residual aspirated specimens for primary culture.
Exclusion Criteria:
- patients did not have residual aspirated specimens for primary culture.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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Patients were divided into AJCC TNM staging < = IIIA and > = IIIB two groups.
The incidences of patients with rapidly proliferative cultured cells in these two groups were compared.
Rapidly proliferative group was defined as (1) growth area of cultured cells at the 28th day of primary culture exceeded two times of the growth area measured at the 14th day, or (2) growth area of cultured cells at the 28th day reached > 70% growth area of the flask.
Based on the results from special stain, patients in rapidly proliferative group were further divided into patients with rapid proliferation of HCC cells alone, rapid proliferation of HCC cells with concomitant cancer-associated fibroblasts (CAFs) (HCC + CAFs) and CAFs alone.
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28 days after plating of cells
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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104 Patients with complete follow-up data were further divided into receiving (1) curative treatment of HCC including operative resection and local ablation therapy, (2) palliative transcatheter arterial chemoembolization (TACE), and (3) supportive treatment.
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6 months after plating of cells
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Zu Y Lin, MD, Kaohsiung Medical University
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.
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
April 1, 2010
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
July 1, 2013
Study Registration Dates
First Submitted
February 7, 2012
First Submitted That Met QC Criteria
March 6, 2012
First Posted (Estimate)
March 9, 2012
Study Record Updates
Last Update Posted (Estimate)
October 8, 2015
Last Update Submitted That Met QC Criteria
September 7, 2015
Last Verified
July 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 990043
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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