Lupus Interval Monitoring to Manage Disease Flare and Enable Treatment Optimization

NCT ID: NCT03142412

Last Updated: 2018-06-28

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 2500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-04-17
• Study Completion Date: 2021-10-17

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.

Detailed Description

Systemic lupus erythematosus (SLE or lupus) is a chronic inflammatory autoimmune disorder of poorly understood etiology associated with a wide range of symptoms and physical findings.

Many patients have incompletely controlled disease progressing to end-stage organ involvement. Recognizing and predicting flares and under associated organ damage would facilitate better treatment timing and selection. Recent improvements in care have dramatically enhanced the survival of lupus patients but increased mortality remains a major concern and current treatments for lupus remain inadequate. Development of novel therapies to manage lupus has been hampered by several challenges, including poorly understood pathogenesis, the heterogeneity of disease activity across and within patient populations, and difficulties conducting interventional studies. There remains a need for reliable and timely monitoring of disease activity and degree of organ damage to adequately evaluate response to treatments and long-term outcome. It is also important to differentiate genuine lupus activity and flares from another intercurrent disease such as infection.

To fill this gap, panels of reliable biomarkers that can classify patients with lupus into more homogenous subsets that are linked to disease activity are needed. Such a panel can be developed from signatures found in lupus patients' transcriptome sequencing data. DxTerity's proprietary DxCollect® Microcollector Device (MCD) is intended to facilitate the collection, stabilization, and shipping of a microsample (about 150μL) of blood. This microsample provides sufficient amounts of quality RNA to perform transcriptome sequencing, allowing identification and validation of candidate biomarker signatures. A rapid blood test to monitor and predict disease activity and treatment response would be an innovative diagnostic product. It could bring significant clinical benefits by enabling the individualized lupus monitoring and treatment to better control the disease and slow organ damage. This may assist with unburdening healthcare costs, help identify flares before they happen, and dramatically improve the management of lupus.

The study will collect participant self-collected blood samples from a fingerstick collection kit that can be done from home and self-reported information from up to 2500 participants for analysis.

Conditions

Systemic Lupus Erythematosus; Lupus; Lupus Erythematosus; Lupus Erythematosus, Systemic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. Male and female patients age 18 or older

2. Have a permanent address in the United States for the duration of the study

3. Have an email address and access to the internet for the duration of the study

4. Able to provide informed consent

5. Self-reported diagnosis of lupus

Exclusion Criteria

1. None

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DxTerity Diagnostics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

DxTerity Diagnostics

Compton, California, United States

Countries

United States

Other Identifiers

DXT-MCD-AD01-LIFT

Identifier Type: -

Identifier Source: org_study_id