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Trial record 19 of 906 for:    Lupus

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

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ClinicalTrials.gov Identifier: NCT04018222
Recruitment Status : Recruiting
First Posted : July 12, 2019
Last Update Posted : July 12, 2019
Sponsor:
Collaborator:
Oklahoma Center for the Advancement of Science and Technology
Information provided by (Responsible Party):
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.

Condition or disease
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.

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Study Type : Observational
Estimated 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
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Group/Cohort
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.



Primary Outcome Measures :
  1. SLEDAI [ Time Frame: Baseline Physician Visit ]
    Systemic Lupus Erythematosus Disease Activity Index - measures the patient's disease activity through clinical and laboratory values

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

  3. SLEDAI [ Time Frame: Six-month Physician Visit ]
    Systemic Lupus Erythematosus Disease Activity Index - measures the patient's disease activity through clinical and laboratory values


Secondary Outcome Measures :
  1. SF-36 [ Time Frame: Baseline at Physician Visit ]
    Short Form 36 Questions. General Wellness measurement

  2. SF-36 [ Time Frame: Month One via Preferred Medium ]
    Short Form 36 Questions. General Wellness measurement

  3. SF-36 [ Time Frame: Month Two via Preferred Medium ]
    Short Form 36 Questions. General Wellness measurement

  4. SF-36 [ Time Frame: Month Three at Physician Visit ]
    Short Form 36 Questions. General Wellness measurement

  5. SF-36 [ Time Frame: Month Four via Preferred Medium ]
    Short Form 36 Questions. General Wellness measurement

  6. SF-36 [ Time Frame: Month Five via Preferred Medium ]
    Short Form 36 Questions. General Wellness measurement

  7. SF-36 [ Time Frame: Month Six at Physician Visit ]
    Short Form 36 Questions. General Wellness measurement


Biospecimen Retention:   Samples With DNA

Patients will submit blood samples beyond what is required for standard of care treatment of Systemic Lupus Erythematosus. The additional blood samples (6 tubes, approximately 9 or 10 teaspoons of blood) will be used for blood-protein evaluation and DNA extraction.

Blood samples are the only biospecimens that will be collected for this study.



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:   Yes
Sampling Method:   Non-Probability Sample
Study Population
60 patients with Systemic Lupus Erythematosus will comprise the study population. These patients will satisfy all inclusion/exclusion criteria for study enrollment.
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT04018222


Contacts
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Contact: Eldon Jupe, Ph.D. +1 (833) 587-8739 ext 3 info@progentec.com
Contact: Ryan D Newhardt, B.S. +1 (405) 213-0605 clinical.research@progentec.com

Locations
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United States, Florida
IRIS Research and Development Recruiting
Fort Lauderdale, Florida, United States, 33324
Contact: Kathy Perez, M.D.    954-476-2338      
United States, Maryland
Arthritis and Pain Associates of PG County Completed
Greenbelt, Maryland, United States, 20770
United States, Pennsylvania
Altoona Center For Clinical Research Recruiting
Duncansville, Pennsylvania, United States, 16635
Contact: Lisa Claycomb    814-690-0300      
Sponsors and Collaborators
Progentec Diagnostics, Inc.
Oklahoma Center for the Advancement of Science and Technology
Investigators
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Principal Investigator: Eldon Jupe, Ph.D. Progentec Diagnostics, Inc.

Additional Information:
Publications:
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Responsible Party: Progentec Diagnostics, Inc.
ClinicalTrials.gov Identifier: NCT04018222     History of Changes
Other Study ID Numbers: OCAST-OARS AR18-019
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
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 Progentec Diagnostics, Inc.:
Systemic Lupus Erythematosus
SLE
Lupus Flare
Flare Prediction
Lupus
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases