Hepatocellular Carcinoma and Rheumatoid Arthritis

NCT ID: NCT02880306

Last Updated: 2016-08-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 741379 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-08-31

Brief 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.

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

RA cohort

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

RA

Intervention Type: OTHER

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

No interventions assigned to this group

Interventions

RA

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: DERIVED

PMID: 30426396 (View on PubMed)

Other Identifiers

05-W01-030

Identifier Type: -

Identifier Source: org_study_id