Hepatocellular CarcinomaNCT03082378
Central Obesity and Hepatocellular Carcinoma
An observational study of Hepatocellular Carcinoma and Obesity, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Recurrence and metastases after microwave ablation(MWA) of hepatocellular carcinoma(HCC) are the major factors that influence the survival. Obesity has been reported was significantly correlated with increased risk of developing HCC. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatocellular Carcinoma, Obesity, Microwave Ablation
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2017to 31 Dec 2019
- 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: HCC patients are treated by ultrasound-guided percutaneous MWA
Who may be able to join
- absence of ascites or the depth of ascites on US detection less than 4 cm;
- a normal serum total bilirubin level or less than 60 µmol/L;
- a normal albumin level or not less than 30 g/L;
- for radical treatment, single lesion of 8 cm or smaller, three or fewer multiple lesions with a maximum diameter of 4 cm or less, absence of portal vein cancerous thrombus or extrahepatic metastases;
- for palliative treatment, those with large or multiple lesions, suffering multiple metastases and unsuitable for other modalities can be considered to undergo the MWA on the condition of good hepatic function and blood coagulation function to tolerate the procedure.
Who cannot join
- clinical evident liver failure, such as massive ascites or hepatic encephalopathy or with a trance-like state
- severe blood coagulation dysfunction (prothrombin time of more than 30 seconds, prothrombin activity less than 40%, and platelet count less than 30 cells×109/L)
- high intrahepatic tumor burden (tumor volume >70% of the target liver volume or multiple tumor nodules) or high extrahepatic tumor burden
- acute or active inflammatory and infectious lesions at any organ
- acute or severe chronic renal failure, pulmonary insufficiency or heart dysfunction
- relative contraindication concerns medical risk for the tumor proximity to diaphragm, gastrointestinal tract, gallbladder, pancreas, hepatic hilum and major bile duct or vessels, which may require adjunctive techniques to prevent off-target heating of adjacent structures during the ablation procedure.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Mengjuan Mu
About this study
Official title: Central Obesity and the Prognosis of Hepatocellular Carcinoma After Microwave Ablation
Recurrence and metastases after microwave ablation(MWA) of hepatocellular carcinoma(HCC) are the major factors that influence the survival. Obesity has been reported was significantly correlated with increased risk of developing HCC.
In this study, we will analysis the association of multiple obesity index(waist circumference,waist-hip ratio and body mass index) with the prognosis of HCC treated by MWA.
- Conditions
- Hepatocellular Carcinoma, Obesity, Microwave Ablation
- Medical subject headings
- Carcinoma, Hepatocellular, Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
survival
Percentage of participants who survived up to end time point as assessed by Kaplan-Meier
Measured: 3 years
Secondary outcomes (4)
intra-hepatic metastasis
Percentage of participants who present metastasis in the liver up to end time point as assessed by Kaplan-Meier
Measured: 3 years
extra-hepatic metastasis
Percentage of participants who present metastasis outside the liver up to end time point as assessed by Kaplan-Meier
Measured: 3 years
local tumor progression
Percentage of participants who present tumor progression around the ablation zone up to end time point as assessed by Kaplan-Meier
Measured: 3 years
complication
number of participants with side effect and major complication
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start1 Mar 2017
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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 crossover
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Jie, Chinese PLA General Hospital
- Investigators
- Jie Yu, Dr, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03082378
- Sponsor's protocol ID
- 301jrcsk
- Status last verified
- Mar 2017
- First submitted
- 12 Mar 2017
- Last updated
- 17 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Obesity and the Prognosis of Hepatocellular Carcinoma After Microwave Ablation
- ClinicalTrials.gov ID
- NCT03082378
- Acronym / sponsor ID
- 301jrcsk
- Conditions
- Hepatocellular Carcinoma, Obesity, Microwave Ablation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 17 Mar 2017 (actual)
- 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 metastases after microwave ablation(MWA) of hepatocellular carcinoma(HCC) are the major factors that influence the survival. Obesity has been reported was significantly correlated with increased risk of developing HCC.
In this study, we will analysis the association of multiple obesity index(waist circumference,waist-hip ratio and body mass index) with the prognosis of HCC treated by MWA.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- HCC patients are treated by ultrasound-guided percutaneous MWA
Key inclusion criteria (5 listed)
- absence of ascites or the depth of ascites on US detection less than 4 cm;
- a normal serum total bilirubin level or less than 60 µmol/L;
- a normal albumin level or not less than 30 g/L;
- for radical treatment, single lesion of 8 cm or smaller, three or fewer multiple lesions with a maximum diameter of 4 cm or less, absence of portal vein cancerous thrombus or extrahepatic metastases;
- for palliative treatment, those with large or multiple lesions, suffering multiple metastases and unsuitable for other modalities can be considered to undergo the MWA on the condition of good hepatic function and blood coagulation function to tolerate the procedure.
Key exclusion criteria (6 listed)
- clinical evident liver failure, such as massive ascites or hepatic encephalopathy or with a trance-like state
- severe blood coagulation dysfunction (prothrombin time of more than 30 seconds, prothrombin activity less than 40%, and platelet count less than 30 cells×109/L)
- high intrahepatic tumor burden (tumor volume >70% of the target liver volume or multiple tumor nodules) or high extrahepatic tumor burden
- acute or active inflammatory and infectious lesions at any organ
- acute or severe chronic renal failure, pulmonary insufficiency or heart dysfunction
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
survival
Time frame: 3 years
Percentage of participants who survived up to end time point as assessed by Kaplan-Meier
4 secondary outcomes
intra-hepatic metastasis
Time frame: 3 years
extra-hepatic metastasis
Time frame: 3 years
local tumor progression
Time frame: 3 years
complication
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2017.
- Individual participant dataSharing planned: No
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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.
Jie Yu, Dr principal investigator
Chinese PLA General 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 Hepatocellular Carcinoma and Obesity, run by Chinese PLA General Hospital at 1 site 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 5 inclusion and 6 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 17 Mar 2017. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Yu, Dr (66939530, yu-jie301@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival (time frame: 3 years). 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 17 Mar 2017.