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Lupus Interval Monitoring to Manage Disease Flare and Enable Treatment Optimization (LIFT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03142412
Recruitment Status : Active, not recruiting
First Posted : May 5, 2017
Last Update Posted : June 28, 2018
Information provided by (Responsible Party):
DxTerity Diagnostics

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.

Condition or disease
Systemic Lupus Erythematosus Lupus Lupus Erythematosus Lupus Erythematosus, Systemic

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.

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Study Type : Observational
Estimated Enrollment : 2500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Lupus Interval Monitoring to Manage Disease Flare and Enable Treatment Optimization
Actual Study Start Date : April 17, 2017
Estimated Primary Completion Date : October 17, 2021
Estimated Study Completion Date : October 17, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Primary Outcome Measures :
  1. Obtain blood samples and associated clinical and demographic data from participants diagnosed with Systemic Lupus Erythematosus (SLE) [ Time Frame: 4.5 years ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants diagnosed with Systemic Lupus Erythematosus (SLE).

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03142412

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United States, California
DxTerity Diagnostics
Compton, California, United States, 90220
Sponsors and Collaborators
DxTerity Diagnostics
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Responsible Party: DxTerity Diagnostics Identifier: NCT03142412    
Other Study ID Numbers: DXT-MCD-AD01-LIFT
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by DxTerity Diagnostics:
Systemic Lupus Erythematosus
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases