NCT01549275

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 9, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

October 8, 2015

Completed
Last Updated

October 8, 2015

Status Verified

July 1, 2013

Enrollment Period

2.8 years

First QC Date

February 7, 2012

Results QC Date

July 15, 2013

Last Update Submit

September 7, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

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

    6 months after plating of cells

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with hepatic tumor measuring larger than or equal to 3 cm underwent fine-needle aspiration of tumor for diagnosis.

You may qualify if:

  • patients had residual aspirated specimens for primary culture.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University Hospital

Kaohsiung City, 807, Taiwan

Location

Related 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. doi: 10.1111/j.1440-1746.2005.04026.x.

    PMID: 16509865BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

cancer cells and cancer-associated fibroblasts

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Results Point of Contact

Title
Dr. Zu-Yau LIn
Organization
Kaohsiung Medical University Hospital

Study Officials

  • Zu Y Lin, MD

    Kaohsiung Medical University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2012

First Posted

March 9, 2012

Study Start

April 1, 2010

Primary Completion

January 1, 2013

Study Completion

July 1, 2013

Last Updated

October 8, 2015

Results First Posted

October 8, 2015

Record last verified: 2013-07

Locations