Identifying Novel Biomarkers in Early Rheumatology Patients

Rheumatologic Disorder Clinical Trial

Official title:

Identifying Novel Biomarkers in Early Rheumatology Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03843658
• Other study ID #: R-18002
• Status: Not yet recruiting
• Start date: March 15, 2019
• Est. completion date: September 15, 2020

Study information

• Verified date: February 2019
• Source: Arthritis Northwest PLLC
• Contact: Terri Cone
• Phone: 5098386500
• Email: tcone[@]arthritisnw.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Patients new to a rheumatology practice will be asked if they want to consent to their blood sample, medical records, and hand/foot x-rays (with sharp scores) for the analysis and correlation with the diagnosis they will receive from the rheumatologist.

Description:

At the end of their first visit new rheumatology patients will be asked for their interest in joining the Inova biomarker study. If yes, the patient will be consented, blood will be drawn for the Inova biomarkers, and x-rays will be sent for sharp scoring. Patients may decline and will not be part of the Inova study. Patients who decline will continue to receive standard of care treatment henceforth.

Patients in the Inova trial will receive a diagnosis from their doctor and are placed into separate cohorts based upon their diagnosis. The Inova biomarker results of each cohort will be cross-correlated with diagnoses, pre-screening tool results. Baseline disease activity and sharp scores will also be correlation variables.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: September 15, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Newly referred Arthritis Northwest PLLC

• Age 18 or older

Exclusion Criteria:

Related Conditions & MeSH terms

• Collagen Diseases
• Rheumatic Diseases
• Rheumatologic Disorder

Intervention

Other:
• There is no intervention, but a diagnosis.
Cohorts will be determined by the primary rheumatology diagnosis.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Arthritis Northwest PLLC	Bristol-Myers Squibb, Inova Diagnostics Inc, University of Nebraska

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The correlation between novel biomarkers and the primary rheumatology diagnosis	Pearson's correlation coefficient of each biomarker to each cohort	18 month enrollment period. No follow-up period