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NCT Number: NCT01549275

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

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.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kaohsiung Medical University Hospital

Kaohsiung City, 807, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients had residual aspirated specimens for primary culture.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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

    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.

Secondary outcomes

  1. 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

    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.

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Collaborators

  • Department of Health, Executive Yuan, R.O.C. (Taiwan)

Registry information

Official study title

Kaohsiung Medical University Hospital

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Mar 9, 2012
Registry last updated
Oct 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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