Hepatitis BTAASNCT02596438
Thousand Asian American Study
An observational study of Hepatitis B, run by University of California, Davis at 1 site in United States.
Trial summary
The "Thousand Asian American Study" or "TAAS" aims to test 2,000 foreign-born and children of foreign born Asian Americans residing in Sacramento county residents for HBV and (2) counsel at least 90% of those whose screening results are positive for HBV. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Hepatitis B
- How many people
- 1,076 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2012to 30 Sep 2017
- How long will I take part?
- 6 Months
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Asian Americans residing in Sacramento, CA who are 18 years of age and older.
Who may be able to join
- All foreign-born Asians and any foreign-born adults born in CDC-defined high to intermediate endemic areas residing in Sacramento County, California.
Who cannot join
- Individuals who have been previously serologically tested for Hepatitis B (self-reported).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis Comprehensive Cancer Center
Sacramento, California, 95817
About this study
Official title: Thousand Asian American Study (TAAS)
The "Thousand Asian American Study" or "TAAS" aims to test 2,000 foreign-born and children of foreign born Asian Americans residing in Sacramento county residents for HBV and (2) counsel at least 90% of those whose screening results are positive for HBV.
Read the detailed description
The "Thousand Asian American Study" or "TAAS" aims to better understand the factors associated with testing for hepatitis B viral (HBV) testing among foreign-born Asian and African adult residents of Sacramento county, characteristics of those infected with HBV, and the efficacy of follow-up and linkage to care for those infected with HBV, and develop a research platform for future studies. Thus, what the investigators want to do is 1) test 2000 foreign-born Sacramento county residents for HBV and (2) counsel at least 90% of those whose screening results are positive for HBV. The investigators want to better characterize factors associated with HBV testing and factors that may differentiate those determined to be free of infection, infected with HBV, and those with resulting primary liver cancer.
- Conditions
- Hepatitis B
- Being tested
- Hepatitis B
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatitis BOther
Hepatitis B Surface Antigen, Hepatitis B Surface Antibody and Hepatitis B Core AB, Total Testing
| Study group | Role | What they receive |
|---|---|---|
| Asian Americans | Foreign born or children of foreign born Asian American from Hepatitis B endemic areas residing in Sacramento, CA. Receives: Other: Hepatitis B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients or adult children of patients born in Hepatitis B endemic countries (rate of 2% or higher) getting screened for hepatitis B.
Measured: 1 year
Secondary outcomes (1)
Number of patients that are hepatitis B positive that receive counseling regarding their infection.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2015 (estimated)
- Study start1 Oct 2012
- Primary completion30 Sep 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 1,076 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moon S Chen Jr., PhD, Principal investigator, UC Davis Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02596438
- Sponsor's protocol ID
- 388325
- Acronym
- TAAS
- Status last verified
- Oct 2017
- First submitted
- 19 Oct 2015
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stewart SL, Dang JH, Torok NJ, Chen MS Jr. Patterns and co-occurrence of risk factors for hepatocellular carcinoma in four Asian American communities: a cross-sectional study. BMJ Open. 2019 Jun 28;9(6):e026409. doi: 10.1136/bmjopen-2018-026409.
PubMed 31256022
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thousand Asian American Study (TAAS)
- ClinicalTrials.gov ID
- NCT02596438
- Acronym / sponsor ID
- TAAS / 388325
- Conditions
- Hepatitis B
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,076 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 1 Oct 2012 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 4 Nov 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.
The "Thousand Asian American Study" or "TAAS" aims to test 2,000 foreign-born and children of foreign born Asian Americans residing in Sacramento county residents for HBV and (2) counsel at least 90% of those whose screening results are positive for HBV.
Detailed description
The "Thousand Asian American Study" or "TAAS" aims to better understand the factors associated with testing for hepatitis B viral (HBV) testing among foreign-born Asian and African adult residents of Sacramento county, characteristics of those infected with HBV, and the efficacy of follow-up and linkage to care for those infected with HBV, and develop a research platform for future studies. Thus, what the investigators want to do is 1) test 2000 foreign-born Sacramento county residents for HBV and (2) counsel at least 90% of those whose screening results are positive for HBV. The investigators want to better characterize factors associated with HBV testing and factors that may differentiate those determined to be free of infection, infected with HBV, and those with resulting primary liver cancer.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asian Americans | – | Other: Hepatitis BForeign born or children of foreign born Asian American from Hepatitis B endemic areas residing in Sacramento, CA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Asian Americans residing in Sacramento, CA who are 18 years of age and older.
Key inclusion criteria (1 listed)
- All foreign-born Asians and any foreign-born adults born in CDC-defined high to intermediate endemic areas residing in Sacramento County, California.
Key exclusion criteria (1 listed)
- Individuals who have been previously serologically tested for Hepatitis B (self-reported).
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 |
|---|---|---|
| Hepatitis BHepatitis B Surface Antigen, Hepatitis B Surface Antibody and Hepatitis B Core AB, Total Testing | Other | Asian Americans |
Primary outcome
Number of patients or adult children of patients born in Hepatitis B endemic countries (rate of 2% or higher) getting screened for hepatitis B.
Time frame: 1 year
1 secondary outcome
Number of patients that are hepatitis B positive that receive counseling regarding their infection.
Time frame: 1 year
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 31 Oct 2017.
- Derived from this study: PubMed 31256022Stewart SL, Dang JH, Torok NJ, Chen MS Jr. Patterns and co-occurrence of risk factors for hepatocellular carcinoma in four Asian American communities: a cross-sectional study. BMJ Open. 2019 Jun 28;9(6):e026409. doi: 10.1136/bmjopen-2018-026409.
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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.
Moon S Chen Jr., PhD principal investigator
UC Davis Comprehensive Cancer Center
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 Hepatitis B, run by University of California, Davis at 1 site in United States.
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 31 Oct 2017. 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 United States. 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?
Number of patients or adult children of patients born in Hepatitis B endemic countries (rate of 2% or higher) getting screened for hepatitis B. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02596438, which also lists 1 linked publication.
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 31 Oct 2017; AzTrials last refreshed its copy on 3 Nov 2026.