Ignite Creation Date:
2024-05-06 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 2:31 PM
Study NCT ID:
NCT05347992
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-02-24
First Post:
2022-04-11
Brief Title:
ELEVATE - Empower Lupus Erythematosus Patients Via Allowing RemoTe Evaluation
Sponsor:
DxTerity Diagnostics
Organization:
DxTerity Diagnostics
Study Overview
Official Title:
ELEVATE - Empower Lupus Erythematosus Patients Via Allowing RemoTe Evaluation
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ELEVATE
Brief Summary:
To explore the potential for use of DxTeritys AIP IFN-1 test as personalized guided care and monitoring module in patients with Systemic lupus erythematosusSLE 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None