Hepatocellular Carcinoma ResectableNCT04177316
Hypermethylation of VTRNA2-1 Promoter in HCC Outcome
An observational study of Hepatocellular Carcinoma Resectable, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The clinic-pathological data were retrieved from the cancer registry database from the Cancer Center of Chang Gung Memorial Hospital, Linkou branch. Of the 92 HCC patients with partial hepatectomies enrolled. The biological specimen was studied with approval. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Hepatocellular Carcinoma Resectable
- How many people
- 92 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2018to 15 Nov 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
- Adult, Older adult
Study population: HCC patients with curative partial hepatectomies and the pathology reports proved.
Who may be able to join
- subjects with pathologic diagnosis of hepatocellular carcinoma curative partial hepatectomies
Who cannot join
- history of different malignant disease. subjects cannot be treated with curative surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Differential Hypermethylation Status of the VTRNA2-1 Promoter in Hepatocellular Carcinoma as an Independent Factor After Partial Hepatectomy
The clinic-pathological data were retrieved from the cancer registry database from the Cancer Center of Chang Gung Memorial Hospital, Linkou branch. Of the 92 HCC patients with partial hepatectomies enrolled. The biological specimen was studied with approval.
Read the detailed description
This study was approved by the Institute Review Board (IRB) of Chang Gung Memorial Hospital, Linkou Branch (IRB 201801969B0). The clinic-pathological data were retrieved from the cancer registry database from the Cancer Center of Chang Gung Memorial Hospital, Linkou branch. Of the 92 HCC patients with partial hepatectomies enrolled, all patients had curative hepatectomy and those with different cancers were excluded. HCC tumor tissue and normal tissue, 3 cm from the tumor margin, were stored immediately in a -80 degree freezer at the Central Biobank of Chang Gung Memorial Hospital. The personal information was protected with decoding and registered with number.
- Conditions
- Hepatocellular Carcinoma Resectable
- Keywords
- VTRNA2-1 promoter, recurrence, methylation
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| hypermethylation | The hypermethylation group was defined as differential methylation status of tumor- normal ≥ 5%. | |
| hypomethylation/no change | The hypomethylation were defined as differential methylation status of tumor- normal <5% |
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 treatment and recurrence or mortality
Measured: a month
Secondary outcomes (1)
Overall survival
The length of time from hepatectomies treatment for HCC 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 posted26 Nov 2019
- Study start1 Dec 2018
- Primary completion15 Nov 2019
- Study completion15 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma ResectableStudies 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
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming-Chin Yu, MD, PhD, Study chair, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04177316
- Sponsor's protocol ID
- 201801969B0
- Status last verified
- Nov 2019
- First submitted
- 22 Nov 2019
- Last updated
- 26 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Hypermethylation Status of the VTRNA2-1 Promoter in Hepatocellular Carcinoma as an Independent Factor After Partial Hepatectomy
- ClinicalTrials.gov ID
- NCT04177316
- Acronym / sponsor ID
- 201801969B0
- Conditions
- Hepatocellular Carcinoma Resectable
- Keywords
- VTRNA2-1 promoter, recurrence, methylation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 15 Nov 2019 (actual)
- First posted
- 26 Nov 2019 (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 clinic-pathological data were retrieved from the cancer registry database from the Cancer Center of Chang Gung Memorial Hospital, Linkou branch. Of the 92 HCC patients with partial hepatectomies enrolled. The biological specimen was studied with approval.
Detailed description
This study was approved by the Institute Review Board (IRB) of Chang Gung Memorial Hospital, Linkou Branch (IRB 201801969B0). The clinic-pathological data were retrieved from the cancer registry database from the Cancer Center of Chang Gung Memorial Hospital, Linkou branch. Of the 92 HCC patients with partial hepatectomies enrolled, all patients had curative hepatectomy and those with different cancers were excluded. HCC tumor tissue and normal tissue, 3 cm from the tumor margin, were stored immediately in a -80 degree freezer at the Central Biobank of Chang Gung Memorial Hospital. The personal information was protected with decoding and registered with number.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hypermethylation | – | –The hypermethylation group was defined as differential methylation status of tumor- normal ≥ 5%. |
| hypomethylation/no change | – | –The hypomethylation were defined as differential methylation status of tumor- normal <5% |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- HCC patients with curative partial hepatectomies and the pathology reports proved.
Key inclusion criteria (1 listed)
- subjects with pathologic diagnosis of hepatocellular carcinoma curative partial hepatectomies
Key exclusion criteria (1 listed)
- history of different malignant disease. subjects 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.
Primary outcome
disease free survival (DFS)
Time frame: a month
The length of time from curative hepatectomies treatment 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 26 Nov 2019.
- Individual participant dataSharing planned: No
Related trials for Hepatocellular Carcinoma Resectable
Not yet recruitingObservational study
Integration of Imaging, Molecular, Pathological, and Clinical Outcome Data in Hepatocellular Carcinoma.
Resectable Hepatocellular Carcinoma (HCC)
Not yet recruitingObservational study
Immune-Related Adverse Events and Clinical Outcomes of First-Line Immunotherapy in Egyptian Patients With Unresectable Hepatocellular Carcinoma
Hepatocellular Carcinoma, Hepatocellular Carcinoma (HCC)
Active, not recruiting
BioPearl™ Microspheres Loaded With Doxorubicin for the Treatment of Unresectable Hepatocellular Carcinoma (HCC)
Hepatocellular Carcinoma Non-resectable
Not yet recruiting
Overcoming Immunotherapy Resistance in Hepatocellular Carcinoma
Hepatocellular Carcinoma Non-Resectable
Active, not recruitingEarly Phase 1
SBRT + Atezolizumab + Bevacizumab in Resectable HCC
Hepatocellular Carcinoma, Resectable Hepatocellular Carcinoma
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.
Ming-Chin Yu, MD, PhD study chair
Chang Gung Memorial Hospital
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 Resectable, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 26 Nov 2019. 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 Taiwan. 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?
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 26 Nov 2019; AzTrials last refreshed its copy on 8 Nov 2026.