Hepatocellular Carcinoma and Rheumatoid Arthritis

Carcinoma, Hepatocellular Clinical Trial

Official title:

Hepatocellular Carcinoma and Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02880306
• Other study ID #: 05-W01-030
• Status: Completed
• Phase: N/A
• First received: August 17, 2016
• Last updated: August 23, 2016
• Start date: July 2014
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 741379
• Est. completion date: August 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Carcinoma
• Carcinoma, Hepatocellular

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the risk of developing hepatocellular carcinoma		between Jan 1, 1999 and Dec 31, 2009	No