Translation of a Diagnostic Test for Lupus Flare Prediction From Bench to Clinic

Study Overview
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Brief Summary
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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 samples for researchers to evaluate the types of proteins that are in their blood. During this time the participant will also visit a research physician to undergo a physical exam that will include an evaluation of the disease's level of activity. Questionnaires will be answered too, either via email, phone call, or a research app for android and iPhone devices. During this six-month period, if the participant experiences a lupus flare, they are strongly encouraged to visit the research physician to receive a complimentary medical evaluation.

Detailed Description
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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 commonly associated with lupus flares and could warn of the risk of a future flare. Participation in this study will involve three separate visits with a research physician for six months. These will proceed as a baseline visit, a three-month visit, and a six-month visit. During each of these visits the physician assesses the participant's physical condition and take blood samples for both research and medical purposes. Throughout this study, the participant will also complete a series of questionnaires to assess their wellness and day-to-day challenges. After the initial visit, the participant will be contacted to complete a monthly survey that evaluates if there have been any changes in your condition. This survey can be completed either via email, a phone call discussion, or the study's unique research app. Three of these six surveys will be completed during the physician's visit, however, the other three will be completed in the preferred medium. Throughout the six-month period while you are on this study, if at any point the participant experiences a flare, they are encouraged to visit the research physician. During this visit, they will receive a physician's evaluation to ensure your medical condition and collect blood samples for our research at no cost to the participant.

Official Title
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Translation of a Diagnostic Test for Lupus Flare Prediction From Bench to Clinic

Conditions
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System; Lupus Erythematosus, Lupus Erythematosus, SLE, Lupus Flare

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lupus Cases<br>This cohort of patients will involve individuals with a confirmed medical history of Systemic Lupus Erythematosus. Qualified individuals will satisfy all Inclusion/Exclusion criteria. | |
| Healthy Controls<br>This cohort of patients will involve individuals whom do not have a diagnosis of Systemic Lupus Erythematosus or any other rheumatological or auto-immune diseases. Qualified individuals will satisfy all Inclusion/Exclusion criteria. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SLEDAI | Systemic Lupus Erythematosus Disease Activity Index - measures the patient's disease activity through clinical and laboratory values | Baseline Physician Visit | 
| SLEDAI | Systemic Lupus Erythematosus Disease Activity Index - measures the patient's disease activity through clinical and laboratory values | Three-month Physician Visit | 
| SLEDAI | Systemic Lupus Erythematosus Disease Activity Index - measures the patient's disease activity through clinical and laboratory values | Six-month Physician Visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-36 | Short Form 36 Questions. General Wellness measurement | Baseline at Physician Visit | 
| SF-36 | Short Form 36 Questions. General Wellness measurement | Month One via Preferred Medium | 
| SF-36 | Short Form 36 Questions. General Wellness measurement | Month Two via Preferred Medium | 
| SF-36 | Short Form 36 Questions. General Wellness measurement | Month Three at Physician Visit | 
| SF-36 | Short Form 36 Questions. General Wellness measurement | Month Four via Preferred Medium | 
| SF-36 | Short Form 36 Questions. General Wellness measurement | Month Five via Preferred Medium | 
| SF-36 | Short Form 36 Questions. General Wellness measurement | Month Six at Physician Visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Systemic Lupus Erythematosus, SLE, Lupus Flare, Flare Prediction, Lupus