NCT03142412

Brief Summary

To develop a test to characterize and monitor SLE disease activity status from a participant's home by analyzing the gene expression from participant self-collected blood samples using a novel fingerstick collection kit.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 17, 2017

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 2, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 5, 2017

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2021

Completed
Last Updated

June 28, 2018

Status Verified

June 1, 2018

Enrollment Period

4.5 years

First QC Date

May 2, 2017

Last Update Submit

June 26, 2018

Conditions

Systemic Lupus ErythematosusLupusLupus ErythematosusLupus Erythematosus, Systemic

Keywords

LupusSLESystemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

  • Obtain blood samples and associated clinical and demographic data from participants diagnosed with Systemic Lupus Erythematosus (SLE)

    Obtain blood samples and associated clinical and demographic data from participants diagnosed with Systemic Lupus Erythematosus (SLE) to develop a blood test to characterize SLE status by analyzing gene expression from blood samples.

    4.5 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants diagnosed with Systemic Lupus Erythematosus (SLE).

You may qualify if:

  • Male and female patients age 18 or older
  • Have a permanent address in the United States for the duration of the study
  • Have an email address and access to the internet for the duration of the study
  • Able to provide informed consent
  • Self-reported diagnosis of lupus

You may not qualify if:

  • \. None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DxTerity Diagnostics

Compton, California, 90220, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2017

First Posted

May 5, 2017

Study Start

April 17, 2017

Primary Completion

October 17, 2021

Study Completion

October 17, 2021

Last Updated

June 28, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)