Hepatocellular CarcinomaNCT03880721
By Developing a Radiomics Model to Predict the Prognosis of Patients With Hepatocellular Carcinoma After Microwave Ablation
An observational study of Hepatocellular Carcinoma, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Developing a radiomics model to predict the prognosis of patients with hepatocellular carcinoma after microwave ablation to provide advice for their treatment. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Microwave abaltion
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to Apr 2021
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with primary hepatocellular carcinoma
Who may be able to join
- Patients with primary hepatocellular carcinoma in the department of interventional ultrasound, PLA general hospital, who accept MWA therapy for HCC
- Primary hepatocellular
- No other treatments ware performed before microwave ablation
- Patient has been clinically diagnosed with HCC definitely, and have a definite operational indication
- No extrahepatic manifestations and no evidence of vessel invasion and bile duct thrombi
Who cannot join
- Non-primary hepatocellular carcinoma or hepatic metastases
- Accept other treatment before microwave ablation
- Extrahepatic metastasis, vessel invasion or bile duct thrombi
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Ping Liang, Doctor
About this study
Developing a radiomics model to predict the prognosis of patients with hepatocellular carcinoma after microwave ablation to provide advice for their treatment.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Microwave abaltion
- Keywords
- radiomics, prognosis
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microwave abaltionProcedure or surgery
Use microwave ablation to treat hepatocellular carcinoma
| Study group | Role | What they receive |
|---|---|---|
| Good prognosis | Not described Receives: Procedure: Microwave abaltion | |
| Poor prognosis | Not described Receives: Procedure: Microwave abaltion | |
| Recurrence | Not described Receives: Procedure: Microwave abaltion | |
| Not Recurrence | Not described Receives: Procedure: Microwave abaltion | |
| Survival | Not described Receives: Procedure: Microwave abaltion | |
| Death | Not described Receives: Procedure: Microwave abaltion |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC value
Utilizing area under curve to judge the accurency
Measured: through study completion, an average of 2 year
Sensitivity
diagnosis sensitivity of intelligent ultrasound analysis
Measured: through study completion, an average of 2 year
Specificity
diagnosis specificity of intelligent ultrasound analysis
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start1 Jan 2019
- Primary completionAug 2020 (estimated)
- Study completionApr 2021 (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
- Cohort
- 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, Ping Liang, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03880721
- Sponsor's protocol ID
- 301jrcsk4
- Status last verified
- May 2019
- First submitted
- 17 Mar 2019
- Last updated
- 24 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- By Developing a Radiomics Model to Predict the Prognosis of Patients With Hepatocellular Carcinoma After Microwave Ablation
- ClinicalTrials.gov ID
- NCT03880721
- Acronym / sponsor ID
- 301jrcsk4
- Conditions
- Hepatocellular Carcinoma
- Keywords
- radiomics, prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 19 Mar 2019 (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.
Developing a radiomics model to predict the prognosis of patients with hepatocellular carcinoma after microwave ablation to provide advice for their treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Good prognosis | – | Procedure: Microwave abaltion |
| Poor prognosis | – | Procedure: Microwave abaltion |
| Recurrence | – | Procedure: Microwave abaltion |
| Not Recurrence | – | Procedure: Microwave abaltion |
| Survival | – | Procedure: Microwave abaltion |
| Death | – | Procedure: Microwave abaltion |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with primary hepatocellular carcinoma
Key inclusion criteria (5 listed)
- Patients with primary hepatocellular carcinoma in the department of interventional ultrasound, PLA general hospital, who accept MWA therapy for HCC
- Primary hepatocellular
- No other treatments ware performed before microwave ablation
- Patient has been clinically diagnosed with HCC definitely, and have a definite operational indication
- No extrahepatic manifestations and no evidence of vessel invasion and bile duct thrombi
Key exclusion criteria (3 listed)
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 |
|---|---|---|
| Microwave abaltionUse microwave ablation to treat hepatocellular carcinoma | Procedure or surgery | Death, Good prognosis, Not Recurrence, Poor prognosis, Recurrence, Survival |
Primary outcome
AUC value
Time frame: through study completion, an average of 2 year
Utilizing area under curve to judge the accurency
Sensitivity
Time frame: through study completion, an average of 2 year
diagnosis sensitivity of intelligent ultrasound analysis
Specificity
Time frame: through study completion, an average of 2 year
diagnosis specificity of intelligent ultrasound analysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2019.
- Individual participant dataSharing planned: Undecided
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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.
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, 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 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: status not confirmed, as of the sponsor's last update on 24 May 2019. 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 (8610-66939530, yu-jie301@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC value (time frame: through study completion, an average of 2 year). The study lists 3 primary outcomes in all. 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 24 May 2019.