Hepatocellular Carcinoma and Rheumatoid Arthritis

August 23, 2016 updated by: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

741379

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
RA cohort
RA was diagnosed based on the 1987 American College of Rheumatology diagnostic criteria.
Other: RA
RA 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the risk of developing hepatocellular carcinoma
Time Frame: between Jan 1, 1999 and Dec 31, 2009
between Jan 1, 1999 and Dec 31, 2009

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

August 17, 2016

First Submitted That Met QC Criteria

August 23, 2016

First Posted (Estimate)

August 26, 2016

Study Record Updates

Last Update Posted (Estimate)

August 26, 2016

Last Update Submitted That Met QC Criteria

August 23, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-W01-030

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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