Carcinoma, HepatocellularCTCs for HCCNCT01930383
Circulating Tumor Cells for Hepatocellular Carcinoma
An observational study of Carcinoma, Hepatocellular and Neoplasm Circulating Cells, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
To explore the clinical value of circulating tumor cells (CTCs) measurement for Hepatocellular carcinoma (HCC) patients. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular, Neoplasm Circulating Cells
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2013to Aug 2015
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hepatocellular carcinoma
Who may be able to join
- Patient must be diagnosed with HCC via one of following methods according to present clinical practice:
- Diagnosed as HCC by biopsy or cytology
- Patients with chronic hepatitis B or other reason induced liver cirrhosis who have diagnosed as HCC based on a typical contrast enhanced CT or MRI profile with malignant lesion [tumor hyper-vascularization].
- Asian male or female subjects >=20 years of age.
- Child-Pugh class A or B liver function..
- HCC patients who will receive anti-cancer therapy, including surgery, radiofrequency ablation therapy, trans-arterial chemoembolization, or systemic therapy (according to current HCC practice guidelines) at National Taiwan University Hospital.
- Signed informed consent.
Who cannot join
- Other significant organ disease or condition his/her investigator judged that the subject should not participate in the study.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Ann-Lii Cheng, PhD
Chih-Hung Hsu, PhD
About this study
Official title: Circulating Tumor Cells (CTCs) as Biomarkers of Prognosis and Predictors of Efficacy of Drug Therapy for Patients With Hepatocellular Carcinoma
To explore the clinical value of circulating tumor cells (CTCs) measurement for Hepatocellular carcinoma (HCC) patients.
Read the detailed description
Background:The lack of tumor tissue for drug target and biomarker studies significantly limit the development of novel treatment for advanced HCC. In recent years, circulating tumor cells (CTCs) have been shown to be important prognostic biomarkers of overall survival for patients with breast, prostate, and colorectal cancer after anti-cancer therapy.
Methods and Materials:This project plans to enroll 50 HCC patients who receive curative surgery or radiofrequency ablation therapy, 50 patients who receive trans-arterial chemoembolization, and 50 patients who receive systemic therapy at National Taiwan University Hospital in 24 months for CTCs analysis. The eligible patients will receive blood tests before and after anti-cancer therapy. The blood samples will be separated to blood cells and plasma. Blood cells will be used for isolation and enumeration of CTCs. Plasma will be used to extract DNA to measure molecular aberration (gene mutations related to hepatocarcinogenesis or response of HCC cells to molecular targeted therapy)
- to explore the correlation between CTCs numbers and other clinical characteristics in HCC patients with different stages;
- to compare the patterns of molecular aberrations between CTC and HCC tumor tissue in HCC patients who have archival tumor tissue available; and
- to measure the changes of CTCs numbers and molecular aberrations in HCC patients before and after molecular targeted therapy.
- Keywords
- biomarkers
- Medical subject headings
- Carcinoma, Hepatocellular, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | HCC patients who receive curative surgery or radiofrequency ablation therapy | |
| Arm B | patients who receive trans-arterial chemoembolization | |
| Arm C | patients who receive systemic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers of circulating tumor cells
CTCs are measured by microfluidic disk platform. They are defined as tumor cells that are circulating in the peripheral blood of patients, which are shed from either the primary tumor or its metastases.
Measured: in 24 months
Secondary outcomes (2)
Overall survival
Measured: 24 months
Clinical characteristics
The other clinical characteristics was defined as following characteristics:
- Sex
- Age
- Barcelona-Clinic Liver Cancer[BCLC] staging
- alpha feto protein[AFP] level
- Time to progression
Measured: in 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2013 (estimated)
- Study startOct 2013
- Primary completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chiun Hsu, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01930383
- Sponsor's protocol ID
- 201306057RIND
- Other IDs
- ctcs201305
- Acronym
- CTCs for HCC
- Status last verified
- Nov 2013
- First submitted
- 20 Aug 2013
- Last updated
- 14 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Tumor Cells (CTCs) as Biomarkers of Prognosis and Predictors of Efficacy of Drug Therapy for Patients With Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT01930383
- Acronym / sponsor ID
- CTCs for HCC / 201306057RIND
- Keywords
- biomarkers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Aug 2015 (estimated)
- First posted
- 28 Aug 2013 (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.
To explore the clinical value of circulating tumor cells (CTCs) measurement for Hepatocellular carcinoma (HCC) patients.
Detailed description
Background:The lack of tumor tissue for drug target and biomarker studies significantly limit the development of novel treatment for advanced HCC. In recent years, circulating tumor cells (CTCs) have been shown to be important prognostic biomarkers of overall survival for patients with breast, prostate, and colorectal cancer after anti-cancer therapy.
Methods and Materials:This project plans to enroll 50 HCC patients who receive curative surgery or radiofrequency ablation therapy, 50 patients who receive trans-arterial chemoembolization, and 50 patients who receive systemic therapy at National Taiwan University Hospital in 24 months for CTCs analysis. The eligible patients will receive blood tests before and after anti-cancer therapy. The blood samples will be separated to blood cells and plasma. Blood cells will be used for isolation and enumeration of CTCs. Plasma will be used to extract DNA to measure molecular aberration (gene mutations related to hepatocarcinogenesis or response of HCC cells to molecular targeted therapy)
- to explore the correlation between CTCs numbers and other clinical characteristics in HCC patients with different stages;
- to compare the patterns of molecular aberrations between CTC and HCC tumor tissue in HCC patients who have archival tumor tissue available; and
- to measure the changes of CTCs numbers and molecular aberrations in HCC patients before and after molecular targeted therapy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | – | –HCC patients who receive curative surgery or radiofrequency ablation therapy |
| Arm B | – | –patients who receive trans-arterial chemoembolization |
| Arm C | – | –patients who receive systemic therapy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hepatocellular carcinoma
Key inclusion criteria (7 listed)
- Patient must be diagnosed with HCC via one of following methods according to present clinical practice:
- Asian male or female subjects >=20 years of age.
- Child-Pugh class A or B liver function..
- HCC patients who will receive anti-cancer therapy, including surgery, radiofrequency ablation therapy, trans-arterial chemoembolization, or systemic therapy (according to current HCC practice guidelines) at National Taiwan University Hospital.
- Signed informed consent.
Key exclusion criteria (1 listed)
- Other significant organ disease or condition his/her investigator judged that the subject should not participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Numbers of circulating tumor cells
Time frame: in 24 months
CTCs are measured by microfluidic disk platform. They are defined as tumor cells that are circulating in the peripheral blood of patients, which are shed from either the primary tumor or its metastases.
2 secondary outcomes
Overall survival
Time frame: 24 months
Clinical characteristics
Time frame: in 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2013.
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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.
Chiun Hsu, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Hepatocellular and Neoplasm Circulating Cells, run by National Taiwan University Hospital at 1 site 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 7 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chiun Hsu, PhD (886-2-23123456 ext. 67009, chsu1967@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numbers of circulating tumor cells (time frame: in 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Nov 2013.