Hepatocellular CarcinomaNCT02587793
Primary Culture of Residual Specimens Obtained From Aspiration of Hepatic Tumor to Predict the Prognosis of the Patients
An observational study of Hepatocellular Carcinoma, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 2 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- not interventional study
- How many people
- 208 participants
- Where
- 2 sitesTaiwan
- Study dates
- Oct 2014to 31 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
Chang Gung Memorial Hospital
Kaohsiung City
About this study
Official title: Kaohsiung Medical University Chung-Ho Memorial Hospital
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.
Read the detailed description
A total of at least 150 patients will be included and followed for at least one year. The proliferative speeds of cultured cells will be classified into (a) rapid proliferation of HCC cells with or without concomitant rapid proliferation of cancer-associated fibroblasts (CAFs), (b) rapid proliferation of CAFs alone, and (c) slow proliferation three groups. The definition for the rapid proliferation of cultured cells fits at least one of the following two items: (1) growth area of cultured cells at the 15th-28th day > two times of the growth area measured at the 14th day, or (2) growth area of cultured cells at the 15th-28th day > 70% growth area of the 25 cm flask. The GraphPad Prism software version 4.03 (GraphPad Software, Inc., La Jolla, CA, USA) is applied for statistical analysis. Influence of the proliferative speeds of cultured cells on survival and cancer progression will be calculated by the logrank test. The statistical significance is defined as P < 0.05.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- not interventional study
- Keywords
- Hepatocellular Carcinoma, primary culture, fine-needle aspiration, cancer-associated fibroblast
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
not interventional studyOther
| Study group | Role | What they receive |
|---|---|---|
| Barcelona Clinic Liver Cancer (BCLC) staging | The tumor stages of the patient are classified as BCLC stage 0, A, B, C, or D. Receives: Other: not interventional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival
Correlation between the proliferative speeds of cultured cells and one year survival of the patients after aspiration of the tumor will be investigated.
Measured: one year
Secondary outcomes (1)
cancer progression
Correlation between the proliferative speeds of cultured cells and HCC progression one year after aspiration of the tumor will be investigated.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study startOct 2014
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zu-Yau Lin, Kaohsiung Medical University Chung-Ho Memorial Hospital
- Investigators
- Zu-Yau Lin, MD, Principal investigator, Kaohsiung Medical University Chung-Ho Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02587793
- Sponsor's protocol ID
- KMUH-IRB-20140182
- Status last verified
- Feb 2019
- First submitted
- 24 Oct 2015
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16509865Lin 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.
PubMed 25087586
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- ClinicalTrials.gov ID
- NCT02587793
- Acronym / sponsor ID
- KMUH-IRB-20140182
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, primary culture, fine-needle aspiration, cancer-associated fibroblast
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 27 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A total of at least 150 patients will be included and followed for at least one year. The proliferative speeds of cultured cells will be classified into (a) rapid proliferation of HCC cells with or without concomitant rapid proliferation of cancer-associated fibroblasts (CAFs), (b) rapid proliferation of CAFs alone, and (c) slow proliferation three groups. The definition for the rapid proliferation of cultured cells fits at least one of the following two items: (1) growth area of cultured cells at the 15th-28th day > two times of the growth area measured at the 14th day, or (2) growth area of cultured cells at the 15th-28th day > 70% growth area of the 25 cm flask. The GraphPad Prism software version 4.03 (GraphPad Software, Inc., La Jolla, CA, USA) is applied for statistical analysis. Influence of the proliferative speeds of cultured cells on survival and cancer progression will be calculated by the logrank test. The statistical significance is defined as P < 0.05.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Barcelona Clinic Liver Cancer (BCLC) staging | – | Other: not interventional studyThe tumor stages of the patient are classified as BCLC stage 0, A, B, C, or D. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| not interventional study | Other | Barcelona Clinic Liver Cancer (BCLC) staging |
Primary outcome
survival
Time frame: one year
Correlation between the proliferative speeds of cultured cells and one year survival of the patients after aspiration of the tumor will be investigated.
1 secondary outcome
cancer progression
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Results publication: PubMed 16509865Lin 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.
- Results publication: PubMed 25087586Lin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zu-Yau Lin, MD principal investigator
Kaohsiung Medical University Chung-Ho Memorial Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02587793, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.