Hepatocellular CarcinomaNCT05837065
Prognostic Models for HCC Based on Tumor Micronecrosis
An observational study of Hepatocellular Carcinoma, run by Zhejiang University at 1 site in China.
Trial summary
The heterogeneity of hepatocellular carcinoma (HCC) leads to the unsatisfying predicting performance of current staging systems. HCC patients with pathological tumor micronecrosis have immunosuppressive microenvironment. 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?
- observing whether HCC patients having tumor micronecrosis
- How many people
- 765 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2022to 30 Dec 2023
- 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: This retrospective study enrolled HCC patients receiving curative hepatectomy in the First Affiliated Hospital, Zhejiang University School of Medicine (FAHZU) (n = 765)
Who may be able to join
- pathologically diagnosed as HCC;
- curative hepatectomy with R0 resection;
- conserved liver function with Child Pugh class A or B
Who cannot join
- with macrovascular invasion or extrahepatic metastasis;
- receiving other anti-tumor treatments such as TACE or systemic drugs;
- with other primary cancers;
- incomplete follow-up data;
- without sufficient formalin-fixed, paraffin-embedded (FFPE) specimens for micronecrosis evaluation
Trial locations and contacts
1 site in 1 country.
Tingbo Liang, PhD contact
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003
Tingbo Liang, MD, PHD, 086-571-87236688, liangtingbo@zju.edu.cn
About this study
Official title: Development and Validation of Novel Models Including Tumor Micronecrosis for Predicting the Postoperative Survival of Patients With Hepatocellular Carcinoma
The heterogeneity of hepatocellular carcinoma (HCC) leads to the unsatisfying predicting performance of current staging systems. HCC patients with pathological tumor micronecrosis have immunosuppressive microenvironment. We aimed to develop novel prognostic models by integrating micronecrosis to more precisely predict the survival of HCC patients after hepatectomy.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- observing whether HCC patients having tumor micronecrosis
- Keywords
- Hepatocellular Carcinoma, Tumor micronecrosis, Nomogram
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observing whether HCC patients having tumor micronecrosisOther
whether HCC patients having tumor micronecrosis or not
| Study group | Role | What they receive |
|---|---|---|
| training cohort | HCC patients receiving curative hepatic resection Receives: Other: observing whether HCC patients having tumor micronecrosis | |
| validation cohort | HCC patients receiving curative hepatic resection Receives: Other: observing whether HCC patients having tumor micronecrosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Harrell concordance index (C-index)
Measured: Up to 5 years
Secondary outcomes (1)
the time-dependent area under the receiver operating characteristic curve(tdAUROC)
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start15 Sep 2022
- Primary completion30 Mar 2023
- Study completion30 Dec 2023 (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.
- 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
- 765 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TingBo Liang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05837065
- Sponsor's protocol ID
- PMforHCC
- Status last verified
- Apr 2023
- First submitted
- 17 Apr 2023
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of Novel Models Including Tumor Micronecrosis for Predicting the Postoperative Survival of Patients With Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05837065
- Acronym / sponsor ID
- PMforHCC
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, Tumor micronecrosis, Nomogram
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 765 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 1 May 2023 (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.
The heterogeneity of hepatocellular carcinoma (HCC) leads to the unsatisfying predicting performance of current staging systems. HCC patients with pathological tumor micronecrosis have immunosuppressive microenvironment. We aimed to develop novel prognostic models by integrating micronecrosis to more precisely predict the survival of HCC patients after hepatectomy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| training cohort | – | Other: observing whether HCC patients having tumor micronecrosisHCC patients receiving curative hepatic resection |
| validation cohort | – | Other: observing whether HCC patients having tumor micronecrosisHCC patients receiving curative hepatic resection |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This retrospective study enrolled HCC patients receiving curative hepatectomy in the First Affiliated Hospital, Zhejiang University School of Medicine (FAHZU) (n = 765)
Key inclusion criteria (3 listed)
- pathologically diagnosed as HCC;
- curative hepatectomy with R0 resection;
- conserved liver function with Child Pugh class A or B
Key exclusion criteria (5 listed)
- with macrovascular invasion or extrahepatic metastasis;
- receiving other anti-tumor treatments such as TACE or systemic drugs;
- with other primary cancers;
- incomplete follow-up data;
- without sufficient formalin-fixed, paraffin-embedded (FFPE) specimens for micronecrosis evaluation
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 |
|---|---|---|
| observing whether HCC patients having tumor micronecrosiswhether HCC patients having tumor micronecrosis or not | Other | training cohort, validation cohort |
Primary outcome
the Harrell concordance index (C-index)
Time frame: Up to 5 years
1 secondary outcome
the time-dependent area under the receiver operating characteristic curve(tdAUROC)
Time frame: Up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- 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.
Tingbo Liang, PhD contact
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 Zhejiang University 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 3 inclusion and 5 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 1 May 2023. 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 Tingbo Liang, PhD (liangtingbo@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Harrell concordance index (C-index) (time frame: Up to 5 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 1 May 2023.