Carcinoma, HepatocellularNCT02880306
Hepatocellular Carcinoma and Rheumatoid Arthritis
An observational study of Carcinoma, Hepatocellular, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation.
Trial summary
Rheumatoid arthritis(RA) is a disorder with altered immunologic function and increased risk of developing malignancies, while studies examining the association between hepatocellular carcinoma (HCC) and RA remain lacking. The investigators aimed to investigate the risk of HCC between participants with and without RA. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- RA
- How many people
- 741,379 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Aug 2016
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All individuals were enrolled prospectively in Taiwan's national health insurance between Jan 1, 1999, and June 30, 2009, and had follow-up data until Dec 31, 2009
Who may be able to join
- subjects were required to have ≥2 RA diagnosis (International Classification of Diseases, Ninth Revision [ICD-9-CM]-codes 714.0x), and to be ≥18 years of age on the date of first diagnosis. And inclusion in the Registry for Catastrophic Illness Patient Database (RCIPD)
Who cannot join
- who were diagnosed with RA only once during the study interval, <18 years of age when first diagnosed with RA, first diagnosed with RA after July 1, 2009, or not registered in the RCIPD were excluded
About this study
Rheumatoid arthritis(RA) is a disorder with altered immunologic function and increased risk of developing malignancies, while studies examining the association between hepatocellular carcinoma (HCC) and RA remain lacking. The investigators aimed to investigate the risk of HCC between participants with and without RA.
Read the detailed description
The investigators did a retrospective, observational, nested case-control study in a cohort that was previously recruited from a population-based RA survey. All participants were enrolled prospectively in Taiwan's national health insurance between Jan 1, 1999, and June 30, 2009, and had follow-up data until Dec 31, 2009. RA was diagnosed based on the 1987 American College of Rheumatology diagnostic criteria. The investigators matched RA and non-RA subjects by propensity score in a 1:1 ratio. The primary outcome was the risk of developing HCC. Cox proportional hazards regression was applied to estimate the hazard ratio (HR) and 95% confidence interval (CI) of HCC for RA and non-RA cohort.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- RA
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAOther
RA was diagnosed based on the 1987 American College of Rheumatology diagnostic criteria
| Study group | Role | What they receive |
|---|---|---|
| RA cohort | RA was diagnosed based on the 1987 American College of Rheumatology diagnostic criteria. Receives: Other: RA | |
| Non-RA cohort | Participants who were ≥18 years of age, without a RA diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
the risk of developing hepatocellular carcinoma
Measured: between Jan 1, 1999 and Dec 31, 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study startJul 2014
- Primary completionMar 2016
- Study completionAug 2016
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 Carcinoma, HepatocellularStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 741,379 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02880306
- Sponsor's protocol ID
- 05-W01-030
- Status last verified
- Aug 2016
- First submitted
- 17 Aug 2016
- Last updated
- 26 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The Taiwan's National Health Insurance Research Database (NHIRD) between Jan 1, 1999, and June 30, 2009, and had follow-up data until Dec 31, 2009. The Taiwan's NHIRD contains health-care data gathered prospectively for 99% of Taiwan's population and approximately 22,600,000 individuals in 2007. The Taiwan's National Health Research Institutes (NHRI) maintained the NHIRD and provided it to the investigators for research purposes. De-identified data were further scrambled before being released to public access for research. The accuracy of diagnosis of major diseases in the NHIRD, such as stroke and acute coronary syndrome, has been validated previously.
Publications
Hsu CS, Lang HC, Huang KY, Chao YC, Chen CL. Risks of hepatocellular carcinoma and cirrhosis-associated complications in patients with rheumatoid arthritis: a 10-year population-based cohort study in Taiwan. Hepatol Int. 2018 Nov;12(6):531-543. doi: 10.1007/s12072-018-9905-7. Epub 2018 Nov 14.
PubMed 30426396
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatocellular Carcinoma and Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT02880306
- Acronym / sponsor ID
- 05-W01-030
- Conditions
- Carcinoma, Hepatocellular
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 741,379 participants (actual)
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 26 Aug 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.
Rheumatoid arthritis(RA) is a disorder with altered immunologic function and increased risk of developing malignancies, while studies examining the association between hepatocellular carcinoma (HCC) and RA remain lacking. The investigators aimed to investigate the risk of HCC between participants with and without RA.
Detailed description
The investigators did a retrospective, observational, nested case-control study in a cohort that was previously recruited from a population-based RA survey. All participants were enrolled prospectively in Taiwan's national health insurance between Jan 1, 1999, and June 30, 2009, and had follow-up data until Dec 31, 2009. RA was diagnosed based on the 1987 American College of Rheumatology diagnostic criteria. The investigators matched RA and non-RA subjects by propensity score in a 1:1 ratio. The primary outcome was the risk of developing HCC. Cox proportional hazards regression was applied to estimate the hazard ratio (HR) and 95% confidence interval (CI) of HCC for RA and non-RA cohort.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RA cohort | – | Other: RARA was diagnosed based on the 1987 American College of Rheumatology diagnostic criteria. |
| Non-RA cohort | – | –Participants who were ≥18 years of age, without a RA diagnosis |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All individuals were enrolled prospectively in Taiwan's national health insurance between Jan 1, 1999, and June 30, 2009, and had follow-up data until Dec 31, 2009
Key inclusion criteria (1 listed)
- subjects were required to have ≥2 RA diagnosis (International Classification of Diseases, Ninth Revision [ICD-9-CM]-codes 714.0x), and to be ≥18 years of age on the date of first diagnosis. And inclusion in the Registry for Catastrophic Illness Patient Database (RCIPD)
Key exclusion criteria (1 listed)
- who were diagnosed with RA only once during the study interval, <18 years of age when first diagnosed with RA, first diagnosed with RA after July 1, 2009, or not registered in the RCIPD were excluded
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 |
|---|---|---|
| RARA was diagnosed based on the 1987 American College of Rheumatology diagnostic criteria | Other | RA cohort |
Primary outcome
the risk of developing hepatocellular carcinoma
Time frame: between Jan 1, 1999 and Dec 31, 2009
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 Aug 2016.
- Derived from this study: PubMed 30426396Hsu CS, Lang HC, Huang KY, Chao YC, Chen CL. Risks of hepatocellular carcinoma and cirrhosis-associated complications in patients with rheumatoid arthritis: a 10-year population-based cohort study in Taiwan. Hepatol Int. 2018 Nov;12(6):531-543. doi: 10.1007/s12072-018-9905-7. Epub 2018 Nov 14.
- Individual participant dataSharing planned: Yes. The Taiwan's National Health Insurance Research Database (NHIRD) between Jan 1, 1999, and June 30, 2009, and had follow-up data until Dec 31, 2009. The Taiwan's NHIRD contains health-care data gathered prospectively for 99% of Taiwan's population and approximately 22,600,000 individuals in 2007. The Taiwan's National Health Research Institutes (NHRI) maintained the NHIRD and provided it to the investigators for research purposes. De-identified data were further scrambled before being released to public access for research. The accuracy of diagnosis of major diseases in the NHIRD, such as stroke and acute coronary syndrome, has been validated previously.
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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.
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 Carcinoma, Hepatocellular, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation.
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 Aug 2016. 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?
the risk of developing hepatocellular carcinoma (time frame: between Jan 1, 1999 and Dec 31, 2009). 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 NCT02880306, 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 26 Aug 2016.