NCT04018222

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Progentec Diagnostics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• System; Lupus Erythematosus
• Lupus Erythematosus
• SLE
• Lupus Flare

Timeline

• Start date: 2019-05-31
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2019-07-12
• Last updated: 2020-09-16

Locations

3 sites across 1 country: United States