HCCNCT05450874
A Novel MSE Score to Predict rHCC Patients
An observational study of HCC, run by Tongji Hospital.
Trial summary
Develop and validate a novel scoring system based on pathological factors to predict the postoperative survival of patients with rHCC.Patients with rHCC who underwent hepatectomy were recruited from two hospitals.Exploring whether this scoring system is related to prognosis Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- HCC
- What is being tested?
- hepatectomy
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2010to 1 Jun 2022
- 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: A total of 221 patients with rHCC who underwent liver resection from February 2010 to March 2016 at Tongji Hospital and 97 patients with rHCC who underwent hepatectomy at Zhongshan People's Hospital during the same period were included in this study
Who may be able to join
- a diagnosis of ruptured tumor confirmed by enhanced computed tomography (CT) and/or abdominal magnetic resonance imaging (MRI),
- a diagnosis of HCC made by two experienced pathologists
Who cannot join
- extrahepatic HCC metastasis
- death within 1 month after surgery
About this study
Official title: A Novel MSE Score to Predict the Postoperative Prognosis of Patients With Ruptured Hepatocellular Carcinoma
Develop and validate a novel scoring system based on pathological factors to predict the postoperative survival of patients with rHCC.Patients with rHCC who underwent hepatectomy were recruited from two hospitals.Exploring whether this scoring system is related to prognosis
- Conditions
- HCC
- Being tested
- hepatectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hepatectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Training cohort | Not described Receives: Procedure: hepatectomy | |
| Validation cohort | Not described Receives: Procedure: hepatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Time from the first postoperative day to survival at the last follow-up
Measured: 2010-2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start1 Feb 2010
- Primary completion1 Mar 2017
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCCStudies of the same condition, open and under way.
- More trials run by Tongji 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
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05450874
- Sponsor's protocol ID
- 2019CFB433
- Status last verified
- Jun 2022
- First submitted
- 5 Jul 2022
- Last updated
- 11 Jul 2022
- Results posted
- 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 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel MSE Score to Predict the Postoperative Prognosis of Patients With Ruptured Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05450874
- Acronym / sponsor ID
- 2019CFB433
- Conditions
- HCC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Feb 2010 (actual)
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 11 Jul 2022 (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 and validate a novel scoring system based on pathological factors to predict the postoperative survival of patients with rHCC.Patients with rHCC who underwent hepatectomy were recruited from two hospitals.Exploring whether this scoring system is related to prognosis
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training cohort | – | Procedure: hepatectomy |
| Validation cohort | – | Procedure: hepatectomy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 221 patients with rHCC who underwent liver resection from February 2010 to March 2016 at Tongji Hospital and 97 patients with rHCC who underwent hepatectomy at Zhongshan People's Hospital during the same period were included in this study
Key inclusion criteria (2 listed)
- a diagnosis of ruptured tumor confirmed by enhanced computed tomography (CT) and/or abdominal magnetic resonance imaging (MRI),
- a diagnosis of HCC made by two experienced pathologists
Key exclusion criteria (2 listed)
- extrahepatic HCC metastasis
- death within 1 month after surgery
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 |
|---|---|---|
| hepatectomy | Procedure or surgery | Training cohort, Validation cohort |
Primary outcome
overall survival
Time frame: 2010-2022
Time from the first postoperative day to survival at the last follow-up
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 11 Jul 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of HCC, run by Tongji Hospital.
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 2 inclusion and 2 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 11 Jul 2022. 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: 2010-2022). 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 11 Jul 2022.