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

Sponsor

Progentec Diagnostics, Inc. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04018222

Collaborator

Oklahoma Center for the Advancement of Science and Technology (Other)

Enrollment

Locations

19.1

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
System; Lupus Erythematosus Lupus Erythematosus SLE Lupus Flare

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 Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 31, 2019

Anticipated Primary Completion Date :

Dec 31, 2020

Anticipated Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Lupus Cases This cohort of patients will involve individuals with a confirmed medical history of Systemic Lupus Erythematosus. Qualified individuals will satisfy all Inclusion/Exclusion criteria.
Healthy Controls This cohort of patients will involve individuals whom do not have a diagnosis of Systemic Lupus Erythematosus or any other rheumatological or auto-immune diseases. Qualified individuals will satisfy all Inclusion/Exclusion criteria.

Outcome Measures

Primary Outcome Measures

SLEDAI [Baseline Physician Visit]
Systemic Lupus Erythematosus Disease Activity Index - measures the patient's disease activity through clinical and laboratory values
SLEDAI [Three-month Physician Visit]
Systemic Lupus Erythematosus Disease Activity Index - measures the patient's disease activity through clinical and laboratory values
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

SF-36 [Baseline at Physician Visit]
Short Form 36 Questions. General Wellness measurement
SF-36 [Month One via Preferred Medium]
Short Form 36 Questions. General Wellness measurement
SF-36 [Month Two via Preferred Medium]
Short Form 36 Questions. General Wellness measurement
SF-36 [Month Three at Physician Visit]
Short Form 36 Questions. General Wellness measurement
SF-36 [Month Four via Preferred Medium]
Short Form 36 Questions. General Wellness measurement
SF-36 [Month Five via Preferred Medium]
Short Form 36 Questions. General Wellness measurement
SF-36 [Month Six at Physician Visit]
Short Form 36 Questions. General Wellness measurement

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

INCLUSION CRITERIA:

Lupus Patients

Females or males age 18 or older
Meet ≥ 4 American College of Rheumatology (ACR) classification criteria for SLE, by medical record review and/or clinical/laboratory assessment OR
Meet ≥ 4 Systemic Lupus Collaborating Clinic (SLICC) classification for SLE, including at least one clinical and one immunologic criterion, by medical record review and/or clinical/laboratory assessment OR
Meet SLE classification by SLICC with ANA positivity
Have a clinical diagnosis of active SLE, per physician assessment
Have the ability to understand the requirements of the study, provide written informed consent including consent for the use and disclosure of research-related health information, and comply with the study data collection procedures

Healthy Controls

Matched to a currently-enrolled patient that is self-reported race, gender, and current age within 5 years.
No medical history of rheumatological or auto-immune diseases.

EXCLUSION CRITERIA:

Active diagnosis of Lupus Nephritis
Inability to comply with the study data collection procedures
Currently being treated with cyclophosphamide
Treated with rituximab within the last six months
Currently being treated with an investigational drug
Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRIS Research and Development	Fort Lauderdale	Florida	United States	33324
2	Arthritis and Pain Associates of PG County	Greenbelt	Maryland	United States	20770
3	Altoona Center For Clinical Research	Duncansville	Pennsylvania	United States	16635