Trials / Completed
CompletedNCT05347992
ELEVATE - (Empower Lupus Erythematosus Patients Via Allowing RemoTe Evaluation)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 423 (actual)
- Sponsor
- DxTerity Diagnostics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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
Detailed description
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.
Conditions
Timeline
- Start date
- 2022-05-03
- Primary completion
- 2023-05-25
- Completion
- 2023-08-17
- First posted
- 2022-04-27
- Last updated
- 2025-01-07
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05347992. Inclusion in this directory is not an endorsement.