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| Name | Class |
|---|---|
| Department of Health, Executive Yuan, R.O.C. (Taiwan) | OTHER_GOV |
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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 | 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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Inclusion Criteria:
Exclusion Criteria:
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patients with hepatic tumor measuring larger than or equal to 3 cm underwent fine-needle aspiration of tumor for diagnosis.
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| Name | Affiliation | Role |
|---|---|---|
| Zu Y Lin, MD | Kaohsiung Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Medical University Hospital | Kaohsiung City | 807 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16509865 | Background | 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. doi: 10.1111/j.1440-1746.2005.04026.x. |
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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.
From April 2010 to January 2013 in Cancer Center and Division of Hepatobiliary Medicine, Department of Internal Medicine, Kaohsiung Medical University Hospital
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | AJCC TNM Staging > = IIIB HCC Patients | 29 patients belonged to AJCC TNM staging > = IIIB. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AJCC TNM Staging < = IIIA HCC Patients | Tumor stage is based on the AJCC (American Joint Committee on Cancer) TNM staging system (2010, 7th edition) |
| BG001 | AJCC TNM Staging > = IIIB HCC Patients |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Comparison the incidence of patients with rapidly proliferative cultured cells between two groups | Posted | Number | participants | 28 days after plating of cells |
|
This study was carried out from April 2010 to January 2013.
This study was to collect the residual specimens obtained from routine aspiration of hepatic tumor. This process did not have any influence on the participants. Serious and other Adverse Events were not collected/assessed."
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HCC Patients Underwent FNA of Tumor | Patients who had residual specimens obtained from ultrasound-guided fine-needle aspiration of hepatic tumor measuring equal or larger than 3cm were included. The residual specimens were applied for primary culture and no additional aspiration of the tumor was performed solely for the collection of specimens for culture. Serious and other Adverse Events were not collected/assessed. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Zu-Yau LIn | Kaohsiung Medical University Hospital | 886-7-323-4553 | linzuyau@yahoo.com.tw |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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cancer cells and cancer-associated fibroblasts
| 6 months after plating of cells |
Tumor stage is based on the AJCC (American Joint Committee on Cancer) TNM staging system (2010, 7th edition)
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| AJCC TNM Staging > = IIIB |
| OG001 | AJCC TNM Staging < = IIIA HCC Patients |
|
|
|
| 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. | Correlation between the growth speeds of cultured cells and worsening of AJCC TNM stages or HCC related death 6 months after plating of cells | Posted | Number | participants | 6 months after plating of cells |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
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| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| Rapid growth and worsening stage or death |
|
| Slow growth and worsening staging or death |
|
| Rapid growth of HCC cells and worsening |
|
Null hypothesis: There is no significant difference in the incidence of change in AJCC TNM stages and survivals 6 months after plating of cells between patients with rapidly and slowly proliferative cultured cells. |
| Fisher Exact |
degrees of freedom = 1 |
| 0.032 |
| 2-Sided |
| No |
| Superiority or Other |
| Null hypothesis: There is no significant difference in the incidence of change in AJCC TNM stages and survivals 6 months after plating of cells between patients with rapidly and slowly proliferative cultured cells. | Fisher Exact | degrees of freedom = 1 | 0.048 | 2-Sided | No | Superiority or Other |
| Null hypothesis: There is no significant difference in the incidence of change in AJCC TNM stages and survivals 6 months after plating of cells between patients with rapidly and slowly proliferative cultured cells. | Fisher Exact | degrees of freedom = 1 | 0.176 | 2-Sided | No | Superiority or Other |
| Null hypothesis: There is no significant difference in the incidence of change in AJCC TNM stages and survivals 6 months after plating of cells between patients with rapidly and slowly proliferative HCC cultured cells. | Fisher Exact | degrees of freedom = 1 | 0.021 | 2-Sided | No | Superiority or Other |
| Null hypothesis: There is no significant difference in the incidence of change in AJCC TNM stages and survivals 6 months after plating of cells between patients with rapidly and slowly proliferative cultured cells. | Fisher Exact | degrees of freedom = 1 | 0.129 | 2-Sided | No | Superiority or Other |