Rupture, SpontaneousNCT03504358
A New Prognostic Scoring System for Spontaneous Ruptured Hepatocellular
An observational study of Rupture, Spontaneous, run by Huazhong University of Science and Technology.
Trial summary
Develop a new scoring system for HCC patients with tumor rupture. Read more about this study
- Who is it for?
- Ages 15 to 75 years
- Conditions the study is for
- Rupture, Spontaneous
- What is being tested?
- Liver resection
- Type of treatment
- Surgery or procedure
- How many people
- 129 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2005to 31 Dec 2017
- 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 15 to 75 years
- All sexes
- Child, Adult, Older adult
Study population: Ten year HCC rupture patients who received partial hepatectomy at Tongji Hospital of the Huazhong University of Science and Technology
Who may be able to join
- Received partial hepatectomy; with Child A or B liver function.
Who cannot join
- Without complete data；loss of follow-up; had reveived repeated transcatheter arterial chemoembolization before rupture; received non-radical resection.
About this study
Official title: A New Prognostic Scoring System for Spontaneous Ruptured Hepatocellular Carcinoma: A Retrospective Study
Develop a new scoring system for HCC patients with tumor rupture.
Read the detailed description
There has been no special prognostic scoring system for HCC patients with tumor rupture in the literature. In this work, we obtained all survival risk factors of ruptured HCC patients who underwent partial hepatectomy using multivariable Cox regression analysis. Furthermore, we develop and validate a new postoperative scoring system for patients with spontaneous HCC rupture based on the these results.
- Conditions
- Rupture, Spontaneous
- Being tested
- Liver resection
- Keywords
- surgery, scoring system, hepatocellular carcinoma, homogeneity and discriminatory ability, survival
- Medical subject headings
- Rupture, Spontaneous, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver resectionProcedure or surgery
Partial hepatectomy comprised single or multiple hepatic resections aiming at excising all visible malignant tissue.
| Study group | Role | What they receive |
|---|---|---|
| Analysis before liver resection | Multivariate analysis of predictive factors associated with survival Receives: Procedure: Liver resection | |
| Different risk group | Low-risk group, moderate-risk group, high-risk group Receives: Procedure: Liver resection | |
| Model comparison | Comparison of models in predicting survival Receives: Procedure: Liver resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival after partial hepatectomy
Measured: 3 years
Secondary outcomes (1)
Disease-free survival
Recurrence-free survival after partial hepatectomy
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 posted20 Apr 2018
- Study start1 Jan 2005
- Primary completion1 May 2015
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rupture, SpontaneousStudies 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoping Chen, Huazhong University of Science and Technology
- Investigators
- Bi-xiang Zhang, Prof, PHD, Study chair, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03504358
- Sponsor's protocol ID
- Zhupeng002
- Status last verified
- Apr 2018
- First submitted
- 4 Apr 2018
- Last updated
- 20 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Prognostic Scoring System for Spontaneous Ruptured Hepatocellular Carcinoma: A Retrospective Study
- ClinicalTrials.gov ID
- NCT03504358
- Acronym / sponsor ID
- Zhupeng002
- Conditions
- Rupture, Spontaneous
- Keywords
- surgery, scoring system, hepatocellular carcinoma, homogeneity and discriminatory ability, survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Jan 2005 (actual)
- Primary completion
- 1 May 2015 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 20 Apr 2018 (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.
Develop a new scoring system for HCC patients with tumor rupture.
Detailed description
There has been no special prognostic scoring system for HCC patients with tumor rupture in the literature. In this work, we obtained all survival risk factors of ruptured HCC patients who underwent partial hepatectomy using multivariable Cox regression analysis. Furthermore, we develop and validate a new postoperative scoring system for patients with spontaneous HCC rupture based on the these results.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Analysis before liver resection | – | Procedure: Liver resectionMultivariate analysis of predictive factors associated with survival |
| Different risk group | – | Procedure: Liver resectionLow-risk group, moderate-risk group, high-risk group |
| Model comparison | – | Procedure: Liver resectionComparison of models in predicting survival |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Ten year HCC rupture patients who received partial hepatectomy at Tongji Hospital of the Huazhong University of Science and Technology
Key inclusion criteria (1 listed)
- Received partial hepatectomy; with Child A or B liver function.
Key exclusion criteria (1 listed)
- Without complete data；loss of follow-up; had reveived repeated transcatheter arterial chemoembolization before rupture; received non-radical resection.
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 |
|---|---|---|
| Liver resectionPartial hepatectomy comprised single or multiple hepatic resections aiming at excising all visible malignant tissue. | Procedure or surgery | Analysis before liver resection, Different risk group, Model comparison |
Primary outcome
Overall survival
Time frame: 3 years
Overall survival after partial hepatectomy
1 secondary outcome
Disease-free survival
Time frame: 3 years
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 20 Apr 2018.
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Latency Antibiotics in Previable PPROM, 18 0/7- 22 6/7 WGA
Rupture of Membranes; Delayed Delivery (Following Spontaneous Rupture), Rupture of Membranes; Premature
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.
Bi-xiang Zhang, Prof, PHD study chair
Huazhong University of Science and Technology
Questions about this trial
What is this clinical trial studying?
An observational study of Rupture, Spontaneous, run by Huazhong University of Science and Technology.
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 1 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: finished, as of the sponsor's last update on 20 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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: 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 20 Apr 2018.