HCCNCT02675920
A Study of HCC High Risk Group Using Two Surveillance Tools
An observational study of HCC, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to compare sensitivity for hepatocellular carcinoma (HCC) of bi-annual ultrasonography and low dose computed tomography (LDCT) in patients at high risk of HCC. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- HCC
- What is being tested?
- non-ionic monomer iodinated CT contrast media
- How many people
- 139 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Nov 2014to 1 Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients at high risk of HCC AND High Risk Index (>=2.33) Risk Index = 1.65 (if the prothrombin activity is <=75%) + 1.41 (if the age is 50 years or older) + 0.92 (if the platelet count is <=100x10(3)/mm3) + 0.74 (if the presence of anti-hepatitis C virus [HCV] or hepatitis B surface antigen [HBsAg] is positive).
Who may be able to join
- All conditions have to be satisfied to be enrolled.
- > 20 years
- high risk group of HCC according to AASLD guideline
- risk index > = 2.33
- currently on regular biannual surveillance using ultrasonography
- sign informed consent
Who cannot join
- Patients with any of following condition cannot be enrolled.
- previously diagnosed with HCC
- any contraindication of contrast enhanced CT including allergic reaction to iodine
- history of other malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Cohort Study to Compare Contrast Enhanced Liver CT and Ultrasonography for Hepatocellular Carcinoma Surveillance in High-risk Group of HCC: Preliminary Study
The purpose of this study is to compare sensitivity for hepatocellular carcinoma (HCC) of bi-annual ultrasonography and low dose computed tomography (LDCT) in patients at high risk of HCC.
Read the detailed description
Patients at high risk of HCC are recommended to undergo biannual surveillance using ultrasound. In this study, LDCT is performed in addition to biannual ultrasound surveillance in eligible patients to compare their sensitivity for HCC. Standard of reference would be follow-up imaging and/or gadoxetic acid-enhanced liver MRI.
- Conditions
- HCC
- Being tested
- non-ionic monomer iodinated CT contrast media
- Keywords
- surveillance, ultrasonography, computed tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-ionic monomer iodinated CT contrast mediaDrug
Also called contrast enhanced CT
patients underwent contrast-enhanced CT using aforementioned CT contrast media (non-ionic monomer iodinated CT contrast media)
| Study group | Role | What they receive |
|---|---|---|
| High risk group of HCC | known high risk group of HCC according to AASLD guideline. And patients whose risk index is equal to or higher than 2.33.
Risk Index = 1.65 (if the prothrombin activity is <=75%) + 1.41 (if the age is 50 years or older) + 0.92 (if the platelet count is <=100x10(3)/mm3) + 0.74 (if the presence of anti-hepatitis C virus [HCV] or hepatitis B surface antigen [HBsAg] is positive).
Patients undergo ultrasonography and LDCT using non-ionic monomer iodinated CT contrast media biannually and the interval between ultrasound and LDCT is within 30 days. Receives: Drug: non-ionic monomer iodinated CT contrast media |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate of patients with HCC
from the 1st LDCT/US screening to six months follow-up after last (12 months after 1st LDCT/US) LDCT/US screening
Measured: 18 months
Secondary outcomes (2)
Detection rate of patients with early HCC
from the 1st LDCT/US screening to six months follow-up after last (12 months after 1st LDCT/US) LDCT/US screening
Measured: 18 months
False referral rate
from the 1st LDCT/US screening to six months follow-up after last (12 month after 1st LDCT/US) LDCT/US screening
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study start28 Nov 2014
- Primary completion11 Jan 2019
- Study completion1 Oct 2019
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 Seoul National University 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
- Prospective
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Taejoon Pharmaceutical Co., Ltd., Reyon Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Jeong Min Lee, Seoul National University Hospital
- Investigators
- Jeong Min Lee, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02675920
- Sponsor's protocol ID
- SNUH-2013-2284
- Status last verified
- Oct 2020
- First submitted
- 1 Feb 2016
- Last updated
- 8 Oct 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 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study to Compare Contrast Enhanced Liver CT and Ultrasonography for Hepatocellular Carcinoma Surveillance in High-risk Group of HCC: Preliminary Study
- ClinicalTrials.gov ID
- NCT02675920
- Acronym / sponsor ID
- SNUH-2013-2284
- Conditions
- HCC
- Keywords
- surveillance, ultrasonography, computed tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Taejoon Pharmaceutical Co., Ltd., Reyon Pharmaceutical Co., Ltd.
- Study start
- 28 Nov 2014 (actual)
- Primary completion
- 11 Jan 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 5 Feb 2016 (estimated)
- 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 purpose of this study is to compare sensitivity for hepatocellular carcinoma (HCC) of bi-annual ultrasonography and low dose computed tomography (LDCT) in patients at high risk of HCC.
Detailed description
Patients at high risk of HCC are recommended to undergo biannual surveillance using ultrasound. In this study, LDCT is performed in addition to biannual ultrasound surveillance in eligible patients to compare their sensitivity for HCC. Standard of reference would be follow-up imaging and/or gadoxetic acid-enhanced liver MRI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High risk group of HCC | – | Drug: non-ionic monomer iodinated CT contrast mediaknown high risk group of HCC according to AASLD guideline. And patients whose risk index is equal to or higher than 2.33. Risk Index = 1.65 (if the prothrombin activity is <=75%) + 1.41 (if the age is 50 years or older) + 0.92 (if the platelet count is <=100x10(3)/mm3) + 0.74 (if the presence of anti-hepatitis C virus [HCV] or hepatitis B surface antigen [HBsAg] is positive). Patients undergo ultrasonography and LDCT using non-ionic monomer iodinated CT contrast media biannually and the interval between ultrasound and LDCT is within 30 days. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at high risk of HCC AND High Risk Index (>=2.33) Risk Index = 1.65 (if the prothrombin activity is <=75%) + 1.41 (if the age is 50 years or older) + 0.92 (if the platelet count is <=100x10(3)/mm3) + 0.74 (if the presence of anti-hepatitis C virus [HCV] or hepatitis B surface antigen [HBsAg] is positive).
Key inclusion criteria (6 listed)
- All conditions have to be satisfied to be enrolled.
- > 20 years
- high risk group of HCC according to AASLD guideline
- risk index > = 2.33
- currently on regular biannual surveillance using ultrasonography
Key exclusion criteria (4 listed)
- Patients with any of following condition cannot be enrolled.
- previously diagnosed with HCC
- any contraindication of contrast enhanced CT including allergic reaction to iodine
- history of other malignancy
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 |
|---|---|---|
| non-ionic monomer iodinated CT contrast mediaAlso: contrast enhanced CTpatients underwent contrast-enhanced CT using aforementioned CT contrast media (non-ionic monomer iodinated CT contrast media) | Drug | High risk group of HCC |
Primary outcome
Detection rate of patients with HCC
Time frame: 18 months
from the 1st LDCT/US screening to six months follow-up after last (12 months after 1st LDCT/US) LDCT/US screening
2 secondary outcomes
Detection rate of patients with early HCC
Time frame: 18 months
False referral rate
Time frame: 18 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 8 Oct 2020.
- 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.
Jeong Min Lee, MD principal investigator
Seoul National University 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 HCC, run by Seoul National University Hospital at 1 site in South Korea.
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 6 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 8 Oct 2020. 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 South Korea. 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?
Detection rate of patients with HCC (time frame: 18 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 8 Oct 2020.