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CompletedNCT02880306Updated Aug 26, 2016

Hepatocellular Carcinoma and Rheumatoid Arthritis

An observational study in Carcinoma, Hepatocellular, sponsored by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation. Completed. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2016-08-26.

Sponsored by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
741,379
Ages
18 Years to 99 Years
Sex
All
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Study 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 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.

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Conditions studied

  • Carcinoma, Hepatocellular
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In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 741,379 is above the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation is the lead sponsor of 55 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
741,379 participants (actual)
Patient registry
No

Groups and cohorts

  • RA cohort

    RA was diagnosed based on the 1987 American College of Rheumatology diagnostic criteria.

    Other: RA

  • Non-RA cohort

    Participants who were ≥18 years of age, without a RA diagnosis

Interventions

  • OtherRA

    RA was diagnosed based on the 1987 American College of Rheumatology diagnostic criteria

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What researchers measure

Primary outcomes

  1. the risk of developing hepatocellular carcinoma

    Time frame: between Jan 1, 1999 and Dec 31, 2009

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Study locations

No study locations are listed for this record.

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References and documents

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 ↗

Individual participant data

Plan to share: 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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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02880306
Lead sponsor
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Responsible party
Sponsor
First posted
Aug 26, 2016
Start date
Jul 2014
Primary completion
Mar 2016
Completion
Aug 2016
Last update
Aug 26, 2016

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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