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

Hepatocellular Carcinoma Clinical Trial

Official title:

Kaohsiung Medical University Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01549275
• Other study ID #: 990043
• Status: Completed
• Phase: N/A
• First received: February 7, 2012
• Last updated: September 7, 2015
• Start date: April 2010
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of HealthTaiwan: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: July 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

• patients had residual aspirated specimens for primary culture.

Exclusion Criteria:

• patients did not have residual aspirated specimens for primary culture.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Hospital	Kaohsiung

Sponsors (2)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital	Department of Health, Executive Yuan, R.O.C. (Taiwan)

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation Between the Growth Speeds of the Cultured Cells and the AJCC TNM Stage (7th Eds) at Entering of the Study.	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.	28 days after plating of cells	No
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	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.	6 months after plating of cells	No