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| Name | Class |
|---|---|
| Oklahoma Center for the Advancement of Science and Technology | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lupus Cases | 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 | 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. |
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| 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 |
| 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 |
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INCLUSION CRITERIA:
Lupus Patients
Healthy Controls
EXCLUSION CRITERIA:
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60 patients with Systemic Lupus Erythematosus will comprise the study population. These patients will satisfy all inclusion/exclusion criteria for study enrollment.
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| Name | Affiliation | Role |
|---|---|---|
| Eldon Jupe, Ph.D. | Progentec Diagnostics, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRIS Research and Development | Fort Lauderdale | Florida | 33324 | United States | ||
| Arthritis and Pain Associates of PG County |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24578190 | Background | Munroe ME, Vista ES, Guthridge JM, Thompson LF, Merrill JT, James JA. Proinflammatory adaptive cytokine and shed tumor necrosis factor receptor levels are elevated preceding systemic lupus erythematosus disease flare. Arthritis Rheumatol. 2014 Jul;66(7):1888-99. doi: 10.1002/art.38573. | |
| 28162788 | Background |
| Label | URL |
|---|---|
| Link to Progentec's website | View source |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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Patients will submit blood samples beyond what is required for standard of care treatment of Systemic Lupus Erythematosus. The additional blood samples (6 tubes, approximately 9 or 10 teaspoons of blood) will be used for blood-protein evaluation and DNA extraction.
Blood samples are the only biospecimens that will be collected for this study.
| 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 |
| Greenbelt |
| Maryland |
| 20770 |
| United States |
| Altoona Center For Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| Munroe ME, Vista ES, Merrill JT, Guthridge JM, Roberts VC, James JA. Pathways of impending disease flare in African-American systemic lupus erythematosus patients. J Autoimmun. 2017 Mar;78:70-78. doi: 10.1016/j.jaut.2016.12.005. Epub 2017 Feb 2. |