Translation of a Diagnostic Test for Lupus Flare Prediction From Bench to Clinic

• Conditions: System; Lupus Erythematosus; SLE; Lupus Flare; Lupus Erythematosus

• Registration Number: NCT04018222
• Lead Sponsor: Progentec Diagnostics, Inc.

Brief Summary

This study is investigating the development of a diagnostic test intended to predict flares in patients with Systemic Lupus Erythematosus. Over a six-month period, the participant will donate blood samples for researchers to evaluate the types of proteins that are in their blood. During this time the participant will also visit a research physician to undergo a physical exam that will include an evaluation of the disease's level of activity. Questionnaires will be answered too, either via email, phone call, or a research app for android and iPhone devices. During this six-month period, if the participant experiences a lupus flare, they are strongly encouraged to visit the research physician to receive a complimentary medical evaluation.

Detailed Description

The purpose of this study is to further validate an algorithm used in a lupus flare-prediction that has been developed. The investigators will be looking at different proteins in the blood that are commonly associated with lupus flares and could warn of the risk of a future flare. Participation in this study will involve three separate visits with a research physician for six months. These will proceed as a baseline visit, a three-month visit, and a six-month visit. During each of these visits the physician assesses the participant's physical condition and take blood samples for both research and medical purposes. Throughout this study, the participant will also complete a series of questionnaires to assess their wellness and day-to-day challenges. After the initial visit, the participant will be contacted to complete a monthly survey that evaluates if there have been any changes in your condition. This survey can be completed either via email, a phone call discussion, or the study's unique research app. Three of these six surveys will be completed during the physician's visit, however, the other three will be completed in the preferred medium. Throughout the six-month period while you are on this study, if at any point the participant experiences a flare, they are encouraged to visit the research physician. During this visit, they will receive a physician's evaluation to ensure your medical condition and collect blood samples for our research at no cost to the participant.

Study Timeline

• Study Start: 2019-05-31
• Study First Submitted: 2019-07-09
• Study First Submitted QC: 2019-07-11
• Study First Posted: 2019-07-12
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-14
• Last Update Posted: 2020-09-16
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SLEDAI	Six-month Physician Visit	Systemic Lupus Erythematosus Disease Activity Index - measures the patient's disease activity through clinical and laboratory values

Secondary Outcome Measures

Name	Time	Method
SF-36	Month Six at Physician Visit	Short Form 36 Questions. General Wellness measurement

Trial Locations

Locations (3)

IRIS Research and Development; 🇺🇸 Fort Lauderdale, Florida, United States

Arthritis and Pain Associates of PG County; 🇺🇸 Greenbelt, Maryland, United States

Altoona Center For Clinical Research; 🇺🇸 Duncansville, Pennsylvania, United States