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To explore the potential for use of DxTerity's AIP IFN-1 test as personalized guided care and monitoring module in patients with Systemic lupus erythematosus(SLE) using consented patient health information
Explore and demonstrate concordance between self-collected samples and traditional phlebotomist venous draw for DxTerity AIP module and biomarkers like C3, C4, anti dsDNA and CRP in SLE participants with self-reported outcomes and medical record data.
The study will collect blood samples and self-reported information for SLE subjects, up to 5000 participants in Phase I, with a subset of 1000 continuing to Phase II with Medical records. Study participants will be recruited using a combination of digital media (including social media, advertising, bloggers, emails). Enrollment and qualification will be done along with consented retrieval of medical records using a study specific mobile app.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Cohort(1) of the study will collect longitudinal blood samples from participants who are on the standard of care treatment for Systemic lupus erythematosus (SLE) based on Cohort specific inclusion criteria | ||
| Biologics | Cohort(2) of the study will collect longitudinal blood samples from participants who are on biologics treatment for Systemic lupus erythematosus (SLE) based on Cohort specific inclusion criteria |
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| Measure | Description | Time Frame |
|---|---|---|
| Concordance between self collected samples and traditional venous draws | Percentage of participants with concordant IFN-1 status as assessed by the DxTerity AIP IFN-1 module, concordance between phlebotomy draw and self-collected blood samples. | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Longitudinal monitoring | Percentage of participants with correlation between IFN-1 high status and increased flares by SAF36 and medical records. | 36 months |
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Inclusion Criteria: (PHASE I)
(PHASE II)
Verified diagnosis (Medical records or /and Physician Questionnaire) for SLE
Report one or more of the following (record all that apply):
Exclusion Criteria:
1. Participants unable to complete study requirements
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Adults diagnosed with SLE
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| Name | Affiliation | Role |
|---|---|---|
| Robert Terbrueggen, PhD | DxTerity Diagnostics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DxTerity Diagnostics, Inc. | Compton | California | 90220 | United States |
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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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Fingerstick blood