Translational Research of SOX4 in Hepatocellular CarcinomaSOX4 in HCCNCT04296058
The Mechanism of Sox4 Transcription in Regulation of Angiogenesis in Hepatocellular Carcinoma
An observational study of Translational Research of SOX4 in Hepatocellular Carcinoma, run by Chang Gung Memorial Hospital.
Trial summary
Two hundred HCC patients with partial hepatectomy were enrolled as a cohort for observational study. The inclusion criterion was intended curative hepatectomy for HCC patients by image analysis, and the exclusion criteria were unresectable disease, synchronous cancers, recurrent cancers, or distant metastasis. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Translational Research of SOX4 in Hepatocellular Carcinoma
- What is being tested?
- microvessel density
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 8 Jan 2007to 31 Mar 2019
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: subjects with pathologic diagnosis of hepatocellular carcinoma
Who may be able to join
- subjects with pathologic diagnosis of hepatocellular carcinoma and curative partial hepatectomies -
Who cannot join
- history of different malignant disease, subject cannot be treated with curative surgery -
About this study
Official title: SOX4 Activates CXCL12 in Hepatocellular Carcinoma Cells to Modulate Endothelial Cell Migration and Angiogenesis in Vivo
Two hundred HCC patients with partial hepatectomy were enrolled as a cohort for observational study. The inclusion criterion was intended curative hepatectomy for HCC patients by image analysis, and the exclusion criteria were unresectable disease, synchronous cancers, recurrent cancers, or distant metastasis. The study endpoint was 30 March 2019, and tumor staging was based on the 8th edition of the American Joint Committee on Cancer (AJCC) TNM staging system for HCC
Read the detailed description
To determine the role of SOX4 in tumor progression in patients with HCC, we examined SOX4 expression through immunohistochemistry (IHC) staining of 200 formalin-fixed and paraffin-embedded (FFPE) HCC specimens . The SOX4 high group of patients was associated with positive etiology of hepatitis B virus (P = 0.044), tumor size >5 cm (P = 0.014), thrombus formation (P = 0.012), higher microvessel density (MVD) (P = 0.012) in tumor lesions, and distant metastasis (P <0.001).
Cox regression analysis showed that patients with elderly age (P <0.001), higher ⍺-fetal protein (AFP) (P = 0.045), presence of cirrhosis (P = 0.008), and SOX4 high in tumor specimen (P = 0.042) were independent risk factors . The SOX4 high group performed significantly worse regarding overall survival (OS) (P = 0.043) and disease-free survival (DFS) (P = 0.019) based on the Kaplan-Meier analysis.
- Being tested
- microvessel density
- Keywords
- SOX4, angiogenesis, microvessel density
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microvessel densityOther
the vessel numbers in high power field with Anti-CD31 staining in tumor specimen
| Study group | Role | What they receive |
|---|---|---|
| SOX4 high | Nuclear expression of SOX4 over 90% in tumor specimen was defined as SOX4 high group Receives: Other: microvessel density | |
| SOX4 low | Nuclear expression of SOX4 less than 90% in tumor specimen was defined as SOX4 low group Receives: Other: microvessel density |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival (DFS)
The length of time from curative hepatectomies and recurrence or mortality
Measured: a month
Secondary outcomes (1)
Overall survival
The length of time from curative hepatectomies and still alive
Measured: a month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start8 Jan 2007
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Translational Research of SOX4 in Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04296058
- Sponsor's protocol ID
- 106-2314-B-182A-113
- Other IDs
- 103-2314-B-182A-082-MY1-3, 106-2314-B-182A-113, CMRPD1G0611, CMRPD1H0661, CMRPG1J0061
- Acronym
- SOX4 in HCC
- Status last verified
- Mar 2019
- First submitted
- 3 Mar 2020
- Last updated
- 5 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SOX4 Activates CXCL12 in Hepatocellular Carcinoma Cells to Modulate Endothelial Cell Migration and Angiogenesis in Vivo
- ClinicalTrials.gov ID
- NCT04296058
- Acronym / sponsor ID
- SOX4 in HCC / 106-2314-B-182A-113
- Keywords
- SOX4, angiogenesis, microvessel density
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- 8 Jan 2007 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 5 Mar 2020 (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.
Two hundred HCC patients with partial hepatectomy were enrolled as a cohort for observational study. The inclusion criterion was intended curative hepatectomy for HCC patients by image analysis, and the exclusion criteria were unresectable disease, synchronous cancers, recurrent cancers, or distant metastasis. The study endpoint was 30 March 2019, and tumor staging was based on the 8th edition of the American Joint Committee on Cancer (AJCC) TNM staging system for HCC
Detailed description
To determine the role of SOX4 in tumor progression in patients with HCC, we examined SOX4 expression through immunohistochemistry (IHC) staining of 200 formalin-fixed and paraffin-embedded (FFPE) HCC specimens . The SOX4 high group of patients was associated with positive etiology of hepatitis B virus (P = 0.044), tumor size >5 cm (P = 0.014), thrombus formation (P = 0.012), higher microvessel density (MVD) (P = 0.012) in tumor lesions, and distant metastasis (P <0.001).
Cox regression analysis showed that patients with elderly age (P <0.001), higher ⍺-fetal protein (AFP) (P = 0.045), presence of cirrhosis (P = 0.008), and SOX4 high in tumor specimen (P = 0.042) were independent risk factors . The SOX4 high group performed significantly worse regarding overall survival (OS) (P = 0.043) and disease-free survival (DFS) (P = 0.019) based on the Kaplan-Meier analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SOX4 high | – | Other: microvessel densityNuclear expression of SOX4 over 90% in tumor specimen was defined as SOX4 high group |
| SOX4 low | – | Other: microvessel densityNuclear expression of SOX4 less than 90% in tumor specimen was defined as SOX4 low group |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- subjects with pathologic diagnosis of hepatocellular carcinoma
Key inclusion criteria (1 listed)
- subjects with pathologic diagnosis of hepatocellular carcinoma and curative partial hepatectomies -
Key exclusion criteria (1 listed)
- history of different malignant disease, subject cannot be treated with curative 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 |
|---|---|---|
| microvessel densitythe vessel numbers in high power field with Anti-CD31 staining in tumor specimen | Other | SOX4 high, SOX4 low |
Primary outcome
Disease free survival (DFS)
Time frame: a month
The length of time from curative hepatectomies and recurrence or mortality
1 secondary outcome
Overall survival
Time frame: a month
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 5 Mar 2020.
- Individual participant dataSharing planned: No
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 Translational Research of SOX4 in Hepatocellular Carcinoma, run by Chang Gung Memorial 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 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 5 Mar 2020. 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?
Disease free survival (DFS) (time frame: a month). 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 5 Mar 2020.