Trial Outcomes & Findings for Primary Cell Culture of Hepatic Tumorous Cells From Routine Fine-needle Aspiration (NCT NCT01549275)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

105 participants

Primary outcome timeframe

28 days after plating of cells

Results posted on

2015-10-08

Participant Flow

From April 2010 to January 2013 in Cancer Center and Division of Hepatobiliary Medicine, Department of Internal Medicine, Kaohsiung Medical University Hospital

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.

Participant milestones

Participant milestones
Measure	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.	AJCC TNM Staging > = IIIB HCC Patients 29 patients belonged to AJCC TNM staging \> = IIIB.
Overall Study STARTED	76	29
Overall Study COMPLETED	75	29
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	AJCC TNM Staging > = IIIB HCC Patients 29 patients belonged to AJCC TNM staging \> = IIIB.
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AJCC TNM Staging < = IIIA HCC Patients n=76 Participants Tumor stage is based on the AJCC (American Joint Committee on Cancer) TNM staging system (2010, 7th edition)	AJCC TNM Staging > = IIIB HCC Patients n=29 Participants Tumor stage is based on the AJCC (American Joint Committee on Cancer) TNM staging system (2010, 7th edition)	Total n=105 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=93 Participants	18 Participants n=4 Participants	49 Participants n=27 Participants
Age, Categorical >=65 years	45 Participants n=93 Participants	11 Participants n=4 Participants	56 Participants n=27 Participants
Age, Continuous	66.4 years STANDARD_DEVIATION 12 • n=93 Participants	59.6 years STANDARD_DEVIATION 14 • n=4 Participants	63.1 years STANDARD_DEVIATION 12.7 • n=27 Participants
Sex: Female, Male Female	14 Participants n=93 Participants	5 Participants n=4 Participants	19 Participants n=27 Participants
Sex: Female, Male Male	62 Participants n=93 Participants	24 Participants n=4 Participants	86 Participants n=27 Participants

PRIMARY outcome

Timeframe: 28 days after plating of cells

Population: Comparison the incidence of patients with rapidly proliferative cultured cells between two groups

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.

Outcome measures

Outcome measures
Measure	AJCC TNM Staging > = IIIB n=29 Participants	AJCC TNM Staging < = IIIA HCC Patients n=76 Participants	TNM Staging < = IIIA Patients Receiving Supportive Treatment 5 patients belonged to BCLC (Barcelona Clinic Liver Cancer classification) degree B and the other 4 patients belonged to BCLC degree C or D.	TNM Staging > = IIIB Patients Receiving TACE All patients belonged to Child A classification and BCLC (Barcelona Clinic Liver Cancer classification) degree C.	TNM Staging > = IIIB Patients Receiving Supportive Treatment All patients belonged to BCLC (Barcelona Clinic Liver Cancer classification) degree C or D.
Correlation Between the Growth Speeds of the Cultured Cells and the AJCC TNM Stage (7th Eds) at Entering of the Study. Rapidly proliferative cultured cells	21 participants	29 participants	—	—	—
Correlation Between the Growth Speeds of the Cultured Cells and the AJCC TNM Stage (7th Eds) at Entering of the Study. Rapid Proliferation of HCC with or without CAFs	14 participants	9 participants	—	—	—
Correlation Between the Growth Speeds of the Cultured Cells and the AJCC TNM Stage (7th Eds) at Entering of the Study. Rapid Proliferation of CAFs alone	7 participants	20 participants	—	—	—

SECONDARY outcome

Timeframe: 6 months after plating of cells

Population: 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.

Outcome measures

Outcome measures
Measure	AJCC TNM Staging > = IIIB n=22 Participants	AJCC TNM Staging < = IIIA HCC Patients n=44 Participants	TNM Staging < = IIIA Patients Receiving Supportive Treatment n=9 Participants 5 patients belonged to BCLC (Barcelona Clinic Liver Cancer classification) degree B and the other 4 patients belonged to BCLC degree C or D.	TNM Staging > = IIIB Patients Receiving TACE n=13 Participants All patients belonged to Child A classification and BCLC (Barcelona Clinic Liver Cancer classification) degree C.	TNM Staging > = IIIB Patients Receiving Supportive Treatment n=16 Participants All patients belonged to BCLC (Barcelona Clinic Liver Cancer classification) degree C or D.
Correlation Between the Growth Speeds of Cultured Cells and Worsening of AJCC TNM Stages or HCC Related Death 6 Months After Plating of Cells Rapidly proliferative cultured cells	10 participants	15 participants	3 participants	9 participants	12 participants
Correlation Between the Growth Speeds of Cultured Cells and Worsening of AJCC TNM Stages or HCC Related Death 6 Months After Plating of Cells Rapid growth and worsening stage or death	0 participants	5 participants	3 participants	4 participants	11 participants
Correlation Between the Growth Speeds of Cultured Cells and Worsening of AJCC TNM Stages or HCC Related Death 6 Months After Plating of Cells Slow growth and worsening staging or death	0 participants	2 participants	1 participants	0 participants	2 participants
Correlation Between the Growth Speeds of Cultured Cells and Worsening of AJCC TNM Stages or HCC Related Death 6 Months After Plating of Cells Rapid growth of HCC cells and worsening	0 participants	2 participants	2 participants	4 participants	8 participants

Adverse Events

HCC Patients Underwent FNA of Tumor

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Zu-Yau LIn

Kaohsiung Medical University Hospital

Phone: 886-7-323-4553

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place