NCT02587793

Brief Summary

The aim of this project is to investigate whether the proliferative speeds of cultured cells using our method can be integrated into Barcelona Clinic Liver Cancer (BCLC) staging classification for the possibility of personalized treatment and prediction the outcomes in hepatocellular carcinoma (HCC) patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
208

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

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

October 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 27, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

3.8 years

First QC Date

October 24, 2015

Last Update Submit

February 26, 2019

Conditions

Keywords

Hepatocellular Carcinomaprimary culturefine-needle aspirationcancer-associated fibroblast

Outcome Measures

Primary Outcomes (1)

  • survival

    Correlation between the proliferative speeds of cultured cells and one year survival of the patients after aspiration of the tumor will be investigated.

    one year

Secondary Outcomes (1)

  • cancer progression

    one year

Study Arms (1)

Barcelona Clinic Liver Cancer (BCLC) staging

The tumor stages of the patient are classified as BCLC stage 0, A, B, C, or D.

Other: not interventional study

Interventions

Barcelona Clinic Liver Cancer (BCLC) staging

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who are proven to have HCC based on fine-needle aspiration of the tumor and also have residual specimens for culture are included.

You may qualify if:

  • Patients are proven to have HCC based on fine-needle aspiration of the tumor.
  • Patient have residual specimens obtained from fine-needle aspiration of the tumor.
  • Patients agree to participate this study after fully explanation.

You may not qualify if:

  • Patients are not proven to have HCC based on fine-needle aspiration of the tumor.
  • Patient do not have residual specimens obtained from fine-needle aspiration of the tumor.
  • Patients do not agree to participate this study after fully explanation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

Location

Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Location

Related Publications (2)

  • 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.

  • Lin ZY, Wu CC, Chuang YH, Chuang WL. Clinical utility of a simple primary culture method in hepatocellular carcinoma patients. J Gastroenterol Hepatol. 2015 Feb;30(2):352-7. doi: 10.1111/jgh.12693.

Biospecimen

Retention: SAMPLES WITH DNA

If the cultured cells can become cell lines, these cell lines will be stored.

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Study Officials

  • Zu-Yau Lin, MD

    Kaohsiung Medical University Chung-Ho Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 24, 2015

First Posted

October 27, 2015

Study Start

October 1, 2014

Primary Completion

July 31, 2018

Study Completion

July 31, 2018

Last Updated

February 27, 2019

Record last verified: 2019-02

Locations