ELEVATE - (Empower Lupus Erythematosus Patients Via Allowing RemoTe Evaluation) (ELEVATE)

February 23, 2023 updated by: DxTerity Diagnostics
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

Study Overview

Status

Active, not recruiting

Conditions

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.

Study Type

Observational

Enrollment (Actual)

423

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Compton, California, United States, 90220
        • DxTerity Diagnostics, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adults diagnosed with SLE

Description

Inclusion Criteria: (PHASE I)

  1. Individuals aged 18 years or older.
  2. Must reside in United States
  3. Have a clinical diagnosis of SLE
  4. Willingness to consent to provide electronic medical records (EMR)
  5. Provide written informed consent and comply with the study procedures.

(PHASE II)

  1. Verified diagnosis (Medical records or /and Physician Questionnaire) for SLE

  2. Report one or more of the following (record all that apply):

    1. Worsening or changes in symptoms or flare
    2. Changes in treatment regimen
    3. On standard of care treatment
    4. On biologics

Exclusion Criteria:

1. Participants unable to complete study requirements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concordance between self collected samples and traditional venous draws
Time Frame: 36 months
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Longitudinal monitoring
Time Frame: 36 months
Percentage of participants with correlation between IFN-1 high status and increased flares by SAF36 and medical records.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DxTerity Diagnostics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2022

Primary Completion (Anticipated)

October 1, 2024

Study Completion (Anticipated)

March 1, 2025

Study Registration Dates

First Submitted

April 11, 2022

First Submitted That Met QC Criteria

April 22, 2022

First Posted (Actual)

April 27, 2022

Study Record Updates

Last Update Posted (Actual)

February 24, 2023

Last Update Submitted That Met QC Criteria

February 23, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DXT-MCD-AI01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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