Status:
UNKNOWN
Translation of a Diagnostic Test for Lupus Flare Prediction From Bench to Clinic
Lead Sponsor:
Progentec Diagnostics, Inc.
Collaborating Sponsors:
Oklahoma Center for the Advancement of Science and Technology
Conditions:
System; Lupus Erythematosus
Lupus Erythematosus
Eligibility:
All Genders
18+ years
Brief Summary
This study is investigating the development of a diagnostic test intended to predict flares in patients with Systemic Lupus Erythematosus. Over a six-month period, the participant will donate blood sa...
Detailed Description
The purpose of this study is to further validate an algorithm used in a lupus flare-prediction that has been developed. The investigators will be looking at different proteins in the blood that are co...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Lupus Patients
- Females or males age 18 or older
- Meet ≥ 4 American College of Rheumatology (ACR) classification criteria for SLE, by medical record review and/or clinical/laboratory assessment OR
- Meet ≥ 4 Systemic Lupus Collaborating Clinic (SLICC) classification for SLE, including at least one clinical and one immunologic criterion, by medical record review and/or clinical/laboratory assessment OR
- Meet SLE classification by SLICC with ANA positivity
- Have a clinical diagnosis of active SLE, per physician assessment
- Have the ability to understand the requirements of the study, provide written informed consent including consent for the use and disclosure of research-related health information, and comply with the study data collection procedures
- Healthy Controls
- Matched to a currently-enrolled patient that is self-reported race, gender, and current age within 5 years.
- No medical history of rheumatological or auto-immune diseases.
- EXCLUSION CRITERIA:
- Active diagnosis of Lupus Nephritis
- Inability to comply with the study data collection procedures
- Currently being treated with cyclophosphamide
- Treated with rituximab within the last six months
- Currently being treated with an investigational drug
- Pregnancy
Exclusion
Key Trial Info
Start Date :
May 31 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04018222
Start Date
May 31 2019
End Date
December 31 2020
Last Update
September 16 2020
Active Locations (3)
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1
IRIS Research and Development
Fort Lauderdale, Florida, United States, 33324
2
Arthritis and Pain Associates of PG County
Greenbelt, Maryland, United States, 20770
3
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States, 16635