NCT02880306

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
741,379

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2014

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 26, 2016

Completed
Last Updated

August 26, 2016

Status Verified

August 1, 2016

Enrollment Period

1.7 years

First QC Date

August 17, 2016

Last Update Submit

August 23, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • the risk of developing hepatocellular carcinoma

    between Jan 1, 1999 and Dec 31, 2009

Study Arms (2)

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

RAOTHER

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

RA cohort

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2016

First Posted

August 26, 2016

Study Start

July 1, 2014

Primary Completion

March 1, 2016

Study Completion

August 1, 2016

Last Updated

August 26, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share

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.