Hepatocellular CarcinomaNCT05739110
HCC Staging Modified by Tumor Micronecrosis
An observational study of Hepatocellular Carcinoma, run by Zhejiang University at 2 sites in China.
Trial summary
Tumor micronecrosis is a pathological feature that reflects malignant biological behavior in hepatocellular carcinoma (HCC). This study aimed to evaluate the prognostic significance of tumor micronecrosis based on the current BCLC and TNM staging systems, and futher improve the performance of the staging models by… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- tumor micronecrosis
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,100 participants
- Where
- 2 sitesChina
- Study dates
- 15 Jul 2022to 15 Jan 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This retrospective study enrolled patients who underwent liver resection from four institutions in China: the First Affiliated Hospital, Zhejiang University School of Medicine (FAHZU) (n = 896), Mengchao Hepatobiliary Hospital of Fujian Medical University (n = 94), the Second Affiliated Hospital of Nanchang University (n = 84), and Huzhou Central Hospital (n = 36).
Who may be able to join
- primary and histologically confirmed HCCs
- patients who underwent curative liver resection
Who cannot join
- simultaneous presence of other tumors
- patients who had received preoperative antitumor therapies
- no available surgical specimens for evaluating micronecrosis status
- gross tumor necrosis and Nscore = 3
Trial locations and contacts
2 sites in 1 country.
China2 sites
the First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003
the First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
About this study
Official title: Optimizing Hepatocellular Carcinoma Disease Staging Systems by Incorporating Tumor Micronecrosis: A Multi-institutional Retrospective Study
Tumor micronecrosis is a pathological feature that reflects malignant biological behavior in hepatocellular carcinoma (HCC). This study aimed to evaluate the prognostic significance of tumor micronecrosis based on the current BCLC and TNM staging systems, and futher improve the performance of the staging models by establishing modified new staging models including tumor micronecrosis.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- tumor micronecrosis
- Keywords
- Hepatocellular carcinoma, Tumor micronecrosis, BCLC, TNM, Disease staging
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tumor micronecrosisBehavioural
whether HCC patients have tumor micronecrosis or not
| Study group | Role | What they receive |
|---|---|---|
| micronecrosis(+) group | Hepatocellular patients with tumor micronecrosis. Receives: Behavioral: tumor micronecrosis | |
| micronecrosis(-) group | Hepatocellular patients without tumor micronecrosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
the number of months from the date of surgery to the date of the last follow-up visit or time of death.
Measured: from date after liver resection until death or last follow-up, whichever came first, assessed up to 72 months
Secondary outcomes (1)
Disease-free survival
the number of months from the date of surgery to the date of first confirmable recurrence or death
Measured: from date after liver resection until recurrence or last follow-up, whichever came first, assessed up to 72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start15 Jul 2022
- Primary completion1 Dec 2022
- Study completion15 Jan 2023
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 Zhejiang UniversityThe 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
- 1,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Huizhou Municipal Central Hospital, Second Affiliated Hospital of Nanchang University, Meng Chao Hepatobiliary Hospital of Fujian Medical University
- Responsible party
- Principal investigator, TingBo Liang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05739110
- Sponsor's protocol ID
- HCCNSTAGE
- Status last verified
- Feb 2023
- First submitted
- 11 Feb 2023
- Last updated
- 22 Feb 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 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Hepatocellular Carcinoma Disease Staging Systems by Incorporating Tumor Micronecrosis: A Multi-institutional Retrospective Study
- ClinicalTrials.gov ID
- NCT05739110
- Acronym / sponsor ID
- HCCNSTAGE
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular carcinoma, Tumor micronecrosis, BCLC, TNM, Disease staging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,100 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Huizhou Municipal Central Hospital, Second Affiliated Hospital of Nanchang University, Meng Chao Hepatobiliary Hospital of Fujian Medical University
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 15 Jan 2023 (actual)
- First posted
- 22 Feb 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.
Tumor micronecrosis is a pathological feature that reflects malignant biological behavior in hepatocellular carcinoma (HCC). This study aimed to evaluate the prognostic significance of tumor micronecrosis based on the current BCLC and TNM staging systems, and futher improve the performance of the staging models by establishing modified new staging models including tumor micronecrosis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| micronecrosis(+) group | – | Behavioral: tumor micronecrosisHepatocellular patients with tumor micronecrosis. |
| micronecrosis(-) group | – | –Hepatocellular patients without tumor micronecrosis. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This retrospective study enrolled patients who underwent liver resection from four institutions in China: the First Affiliated Hospital, Zhejiang University School of Medicine (FAHZU) (n = 896), Mengchao Hepatobiliary Hospital of Fujian Medical University (n = 94), the Second Affiliated Hospital of Nanchang University (n = 84), and Huzhou Central Hospital (n = 36).
Key inclusion criteria (2 listed)
- primary and histologically confirmed HCCs
- patients who underwent curative liver resection
Key exclusion criteria (4 listed)
- simultaneous presence of other tumors
- patients who had received preoperative antitumor therapies
- no available surgical specimens for evaluating micronecrosis status
- gross tumor necrosis and Nscore = 3
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 |
|---|---|---|
| tumor micronecrosiswhether HCC patients have tumor micronecrosis or not | Behavioural | micronecrosis(+) group |
Primary outcome
Overall survival
Time frame: from date after liver resection until death or last follow-up, whichever came first, assessed up to 72 months
the number of months from the date of surgery to the date of the last follow-up visit or time of death.
1 secondary outcome
Disease-free survival
Time frame: from date after liver resection until recurrence or last follow-up, whichever came first, assessed up to 72 months
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 22 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 2 sites 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 2 inclusion and 4 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 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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: from date after liver resection until death or last follow-up, whichever came first, assessed up to 72 months). 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 22 Feb 2023.