Hepatocellular Carcinoma;NCT01786980
The Methylation Phenotype Screening and Determination Mode Study of Liver Cancer Prognosis Related Gene
An observational study of Hepatocellular Carcinoma; and Radical Hepatic Resection;, run by Eastern Hepatobiliary Surgery Hospital at 2 sites in China.
Trial summary
Recurrence and metastasis are the main factors affecting the prognosis of liver cancer after curative resection. Establishing an effective prognostic evaluation method is able to not only assess patients' prognosis but also guide the treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma;, Radical Hepatic Resection;
- How many people
- 300 participants
- Where
- 2 sitesChina
- Study dates
- Oct 2012to Dec 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients with radical hepatectomy in Eastern Hepatobiliary Surgery Hospital, and were confirmed hepatocellular carcinoma pathologically. The liver function was Child-Pugh A, as well as the Child-Pugh B achieved to A after treatment, and the HAI score of cirrhosis was <12.
Who may be able to join
- Patients with radical hepatectomy in Eastern Hepatobiliary Surgery Hospital;
- Hepatocellular carcinoma confirmed pathologically;
- The liver function is Child-Pugh A, as well as the Child-Pugh B achieved to A after treatment;
- The HAI score of cirrhosis <12
Who cannot join
- Patients with apparent cardiac, pulmonary, cerebric and renal dysfunction,which may affect the treatment of liver cancer.
- Patients with other diseases which may affect the treatment mentioned here.
- Patients with medical history of other malignant tumors.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Eastern Hepatobiliary Surgery Hospital
Shanghai, Shanghai Municipality, 200438
Eastern hepatobilliary surgery hospital
Shanghai, Shanghai Municipality, 200438
About this study
Recurrence and metastasis are the main factors affecting the prognosis of liver cancer after curative resection. Establishing an effective prognostic evaluation method is able to not only assess patients' prognosis but also guide the treatment. At the same time, it helps us to gain knowledge of the mechanism underlying recurrence and metastasis of liver cancer and to provide the basis for the search for new effective intervention method.
In order to establish an effective prognostic evaluation method, we select liver cancer patients undergoing curative resection in our hospital. We plan to employ various technologies such as gene chip, methylation chip and flow cytometry to carry out comprehensive researches on liver cancer cell genetics, epigenetics, stem cells and tumor microenvironment changes. By analyzing clinical information including pathological features, patients' response to treatment, relapse, metastasis and survival, we aim to obtain the important factors affecting liver cancer prognosis, survival, recurrence and metastasis in order to be able to find and establish the effective prognostic evaluation method.
Read the detailed description
Recurrence and metastasis are the main factors affecting the prognosis of liver cancer after curative resection. Establishing an effective prognostic evaluation method is able to not only assess patients' prognosis but also guide the treatment. At the same time, it helps us to gain knowledge of the mechanism underlying recurrence and metastasis of liver cancer and to provide the basis for the search for new effective intervention method.
In order to establish an effective prognostic evaluation method, we select liver cancer patients undergoing curative resection in our hospital. We plan to employ various technologies such as gene chip, methylation chip and flow cytometry to carry out comprehensive researches on liver cancer cell genetics, epigenetics, stem cells and tumor microenvironment changes. By analyzing clinical information including pathological features, patients' response to treatment, relapse, metastasis and survival, we aim to obtain the important factors affecting liver cancer prognosis, survival, recurrence and metastasis in order to be able to find and establish the effective prognostic evaluation method.
- Medical subject headings
- Carcinoma, Hepatocellular
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 |
|---|---|---|
| liver cancer, Radical hepatic resection | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Study startOct 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma;Studies of the same condition, open and under way.
- 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
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Hepatobiliary Surgery Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ShenFeng, Eastern Hepatobiliary Surgery Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01786980
- Sponsor's protocol ID
- 2012ZX1000201600104
- Status last verified
- Mar 2016
- First submitted
- 6 Feb 2013
- Last updated
- 1 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Methylation Phenotype Screening and Determination Mode Study of Liver Cancer Prognosis Related Gene
- ClinicalTrials.gov ID
- NCT01786980
- Acronym / sponsor ID
- 2012ZX1000201600104
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Eastern Hepatobiliary Surgery HospitalUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 8 Feb 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.
Recurrence and metastasis are the main factors affecting the prognosis of liver cancer after curative resection. Establishing an effective prognostic evaluation method is able to not only assess patients' prognosis but also guide the treatment. At the same time, it helps us to gain knowledge of the mechanism underlying recurrence and metastasis of liver cancer and to provide the basis for the search for new effective intervention method.
In order to establish an effective prognostic evaluation method, we select liver cancer patients undergoing curative resection in our hospital. We plan to employ various technologies such as gene chip, methylation chip and flow cytometry to carry out comprehensive researches on liver cancer cell genetics, epigenetics, stem cells and tumor microenvironment changes. By analyzing clinical information including pathological features, patients' response to treatment, relapse, metastasis and survival, we aim to obtain the important factors affecting liver cancer prognosis, survival, recurrence and metastasis in order to be able to find and establish the effective prognostic evaluation method.
Detailed description
Recurrence and metastasis are the main factors affecting the prognosis of liver cancer after curative resection. Establishing an effective prognostic evaluation method is able to not only assess patients' prognosis but also guide the treatment. At the same time, it helps us to gain knowledge of the mechanism underlying recurrence and metastasis of liver cancer and to provide the basis for the search for new effective intervention method.
In order to establish an effective prognostic evaluation method, we select liver cancer patients undergoing curative resection in our hospital. We plan to employ various technologies such as gene chip, methylation chip and flow cytometry to carry out comprehensive researches on liver cancer cell genetics, epigenetics, stem cells and tumor microenvironment changes. By analyzing clinical information including pathological features, patients' response to treatment, relapse, metastasis and survival, we aim to obtain the important factors affecting liver cancer prognosis, survival, recurrence and metastasis in order to be able to find and establish the effective prognostic evaluation method.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| liver cancer, Radical hepatic resection | – | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients with radical hepatectomy in Eastern Hepatobiliary Surgery Hospital, and were confirmed hepatocellular carcinoma pathologically. The liver function was Child-Pugh A, as well as the Child-Pugh B achieved to A after treatment, and the HAI score of cirrhosis was <12.
Key inclusion criteria (4 listed)
- Patients with radical hepatectomy in Eastern Hepatobiliary Surgery Hospital;
- Hepatocellular carcinoma confirmed pathologically;
- The liver function is Child-Pugh A, as well as the Child-Pugh B achieved to A after treatment;
- The HAI score of cirrhosis <12
Key exclusion criteria (3 listed)
- Patients with apparent cardiac, pulmonary, cerebric and renal dysfunction,which may affect the treatment of liver cancer.
- Patients with other diseases which may affect the treatment mentioned here.
- Patients with medical history of other malignant tumors.
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
Overall survival
Time frame: 2015
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 1 Apr 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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; and Radical Hepatic Resection;, run by Eastern Hepatobiliary Surgery Hospital at 2 sites in China.
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 4 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 1 Apr 2016. 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 China. 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?
Overall survival (time frame: 2015). 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 1 Apr 2016.