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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.
 
ClinicalTrials.gov Identifier: NCT03142412
Recruitment Status : Active, not recruiting
First Posted : May 5, 2017
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
DxTerity Diagnostics

Tracking Information
First Submitted Date May 2, 2017
First Posted Date May 5, 2017
Last Update Posted Date June 28, 2018
Actual Study Start Date April 17, 2017
Estimated Primary Completion Date October 17, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 3, 2017)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Lupus Interval Monitoring to Manage Disease Flare and Enable Treatment Optimization
Official Title Lupus Interval Monitoring to Manage Disease Flare and Enable Treatment Optimization
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants diagnosed with Systemic Lupus Erythematosus (SLE).
Condition
  • Systemic Lupus Erythematosus
  • Lupus
  • Lupus Erythematosus
  • Lupus Erythematosus, Systemic
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: May 3, 2017)
2500
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 17, 2021
Estimated Primary Completion Date October 17, 2021   (Final data collection date for primary outcome measure)
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

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03142412
Other Study ID Numbers DXT-MCD-AD01-LIFT
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party DxTerity Diagnostics
Study Sponsor DxTerity Diagnostics
Collaborators Not Provided
Investigators Not Provided
PRS Account DxTerity Diagnostics
Verification Date June 2018