Liver NeoplasmsHCCNCT02501980
Hepatocellular Cancer (HCC) Screening in Zhongshan City
An observational study of Liver Neoplasms, run by Zhongshan People's Hospital, Guangdong, China at 1 site in China.
Trial summary
All participants in the selected communities will be tested for HBsAg by using serum samples. Among those who are positive for HBsAg, further clinical work-ups including AFP test and ultrasonography for liver exam will be performed. High risk group will be selected according to the definition. Read more about this study
- Who is it for?
- Ages 35 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Neoplasms
- What is being tested?
- Biomarker testing and Ultrasonography
- How many people
- 20,000 participants
- Where
- 1 siteChina
- Study dates
- Jan 2012to Dec 2024
- How long will I take part?
- 10 Years
- 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 35 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy residences in Zhongshan City.
Who may be able to join
- Residences in Zhongshan City
- Have no medical records of hepatocellular cancer
- ECOG 0-2
- Provide written informed consent forms
- Have a good physical and psychological condition
Who cannot join
- Have severe cardiovascular or kidney disease
- Have medical records of hepatocellular cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Searching for Early Detection Biomarkers and to Reduce Mortality Rate of Hepatocellular Cancer (HCC) in Zhongshan City
All participants in the selected communities will be tested for HBsAg by using serum samples. Among those who are positive for HBsAg, further clinical work-ups including AFP test and ultrasonography for liver exam will be performed. High risk group will be selected according to the definition. HCC diagnosis will be determined according to imaging and/or biopsy result. Repeated check-ups will be performed in 6-months among HBsAg positive group and 3-years among HBsAg negative group.
All subjects in the control arm (control communities) will be followed by record linkage to Cancer Register and Population Register.
Read the detailed description
Sample selection
- Select communities of 70,000 to 120,000 populations in Zhongshan City as the investigators' fields.
- Divide them into screening group and control group according to the areas of administration
Participants recruitment
- Subjects voluntarily attend this screening study
Informed consent - Informed consent forms will be collected at the recruitment.
Questionnaires
- Face-to-face interviews are conducted by well-trained investigators
Serological tests
- Each blood samples will be tested for the surface antigen of the hepatitis B virus (HBsAg).
- Among those who are positive for HBsAg, further clinical work-ups including Alpha-Fetoprotein(AFP) test and ultrasonography for liver exam will be performed and high risk group will be selected according to the definition.
- HCC diagnosis will be determined according to imaging and/or biopsy result.
- The rest of the blood samples will be stored at the biobank of Zhongshan People's Hospital.
Follow up
- The cohort will follow up according to the screening protocol. Briefly, Repeated check-ups will be performed in 6-months among HBsAg positive group and 3-years among HBsAg negative group.
- All subjects in the control arm (control communities) will be followed by record linkage to Cancer Register and Population Register.
- Conditions
- Liver Neoplasms
- Being tested
- Biomarker testing and Ultrasonography
- Keywords
- Screening, Hepatocellular Cancer, Biomarker, Mortality rate
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarker testing and UltrasonographyBiological
| Study group | Role | What they receive |
|---|---|---|
| Screening | All participants will be tested for HBsAg by using serum samples. Among those who are positive for HBsAg, further clinical work-ups including AFP test and ultrasonography for liver exam will be performed. Repeated check-ups will be performed in 6-months among HBsAg positive group and 3-years among HBsAg negative group. Receives: Biological: Biomarker testing and Ultrasonography | |
| Non-screening | All subjects in this arm will be followed by linkage to Cancer Register and Population Register. |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year HCC specific mortality rate
To reduce 5-year HCC specific mortality rate compare with that of general population
Measured: 10 years
Secondary outcomes (2)
Early diagnosis rate of HCC
To improve early diagnosis rate of HCC compare with that of general population
Measured: 5 years
Identification of early diagnosis markers of HCC
To identify early expression markers of HCC
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2015 (estimated)
- Study startJan 2012
- Primary completionJan 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver NeoplasmsStudies 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
- Prospective
- Enrolment
- 20,000 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Zhongshan People's Hospital, Guangdong, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mingfang Ji, Zhongshan People's Hospital, Guangdong, China
- Investigators
- Mingfang Ji, MD, Principal investigator, Zhongshan People's Hospital, Guangdong, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02501980
- Sponsor's protocol ID
- HCC-PRO-001
- Acronym
- HCC
- Status last verified
- Jul 2023
- First submitted
- 11 Jun 2015
- Last updated
- 13 Jul 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Searching for Early Detection Biomarkers and to Reduce Mortality Rate of Hepatocellular Cancer (HCC) in Zhongshan City
- ClinicalTrials.gov ID
- NCT02501980
- Acronym / sponsor ID
- HCC / HCC-PRO-001
- Conditions
- Liver Neoplasms
- Keywords
- Screening, Hepatocellular Cancer, Biomarker, Mortality rate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (actual)
- Lead sponsor
- Zhongshan People's Hospital, Guangdong, ChinaUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 17 Jul 2015 (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.
All participants in the selected communities will be tested for HBsAg by using serum samples. Among those who are positive for HBsAg, further clinical work-ups including AFP test and ultrasonography for liver exam will be performed. High risk group will be selected according to the definition. HCC diagnosis will be determined according to imaging and/or biopsy result. Repeated check-ups will be performed in 6-months among HBsAg positive group and 3-years among HBsAg negative group.
All subjects in the control arm (control communities) will be followed by record linkage to Cancer Register and Population Register.
Detailed description
Sample selection
- Select communities of 70,000 to 120,000 populations in Zhongshan City as the investigators' fields.
- Divide them into screening group and control group according to the areas of administration
Participants recruitment
- Subjects voluntarily attend this screening study
Informed consent - Informed consent forms will be collected at the recruitment.
Questionnaires
- Face-to-face interviews are conducted by well-trained investigators
Serological tests
- Each blood samples will be tested for the surface antigen of the hepatitis B virus (HBsAg).
- Among those who are positive for HBsAg, further clinical work-ups including Alpha-Fetoprotein(AFP) test and ultrasonography for liver exam will be performed and high risk group will be selected according to the definition.
- HCC diagnosis will be determined according to imaging and/or biopsy result.
- The rest of the blood samples will be stored at the biobank of Zhongshan People's Hospital.
Follow up
- The cohort will follow up according to the screening protocol. Briefly, Repeated check-ups will be performed in 6-months among HBsAg positive group and 3-years among HBsAg negative group.
- All subjects in the control arm (control communities) will be followed by record linkage to Cancer Register and Population Register.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Screening | – | Biological: Biomarker testing and UltrasonographyAll participants will be tested for HBsAg by using serum samples. Among those who are positive for HBsAg, further clinical work-ups including AFP test and ultrasonography for liver exam will be performed. Repeated check-ups will be performed in 6-months among HBsAg positive group and 3-years among HBsAg negative group. |
| Non-screening | – | –All subjects in this arm will be followed by linkage to Cancer Register and Population Register. |
Who may qualify
- Ages
- 35 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy residences in Zhongshan City.
Key inclusion criteria (5 listed)
- Residences in Zhongshan City
- Have no medical records of hepatocellular cancer
- ECOG 0-2
- Provide written informed consent forms
- Have a good physical and psychological condition
Key exclusion criteria (2 listed)
- Have severe cardiovascular or kidney disease
- Have medical records of hepatocellular cancer
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 |
|---|---|---|
| Biomarker testing and Ultrasonography | Biological | Screening |
Primary outcome
5-year HCC specific mortality rate
Time frame: 10 years
To reduce 5-year HCC specific mortality rate compare with that of general population
2 secondary outcomes
Early diagnosis rate of HCC
Time frame: 5 years
Identification of early diagnosis markers of HCC
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
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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.
Mingfang Ji, MD principal investigator
Zhongshan People's Hospital, Guangdong, China
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 Liver Neoplasms, run by Zhongshan People's Hospital, Guangdong, China 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 5 inclusion and 2 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 13 Jul 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?
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?
5-year HCC specific mortality rate (time frame: 10 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 13 Jul 2023.