# Core 2 - Clinical Core

> **NIH NIH P50** · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · 2021 · $191,040

## Abstract

ABSTRACT
Understanding Systemic Lupus Erythematosus (SLE) presents a formidable challenge to both the basic
scientist and the clinician, given its undulating and often unpredictable course, variability among different
racial/ethnic groups, and dearth of approved medications. The Clinical Core of the Translational Center of
Molecular Profiling in Preclinical and Established Lupus will be the foundation for three Research Projects
that focus on molecular comparisons and contrasts between clinically asymptomatic and symptomatic
autoimmunity to elucidate protective, inciting, and perpetuating events in the pathogenesis of SLE. The Clinical
Core will leverage access to two unique sources of patient material: 1) the Research Registry for Neonatal
Lupus (RRNL), which provides a rare opportunity to study asymptomatic women at risk for developing SLE
who are identified to have anti-Ro antibodies solely based on the diagnosis of neonatal lupus in an offspring; 2)
the NYU Lupus Cohort, a large well-characterized prospective multiracial/ethnic cohort; and 3) healthy controls
age, ethnically/racially, and gender matched to subjects. The Clinical Core will provide detailed phenotypic
analysis of these two cohorts by linking clinical data inclusive of validated disease activity and flare instruments
specific to Lupus to precisely define timing of flares and remissions with biologic inquiries related to genetics,
the microbiome, B and T cells, and autoantibody profiles. These goals will be accomplished via three specific
aims: Specific Aim 1 will develop and maintain a clinical database and linked sample repository
comprised of mothers enrolled in the RRNL and a prospectively followed cohort of subjects with overt
SLE. Clinical data will be matched with subject blood and stool samples (specific to the needs of the Research
Projects), which will be stored and maintained by the Clinical Core. Specific Aim 2 will establish a workflow
for the delivery of specimens and linked clinical data to investigators in Projects 1, 2, and 3 with sample
procurement coordinated to provide both fresh and stored specimens driven by the research protocols.
Specific Aim 3 will incorporate appropriate statistical resources to perform analyses correlating
research data with matched clinical data. It is anticipated that the Clinical Core will provide an
unprecedented platform upon which state-of-the-art technologies can be applied to precisely phenotyped and
longitudinally followed cohorts.

## Key facts

- **NIH application ID:** 10249212
- **Project number:** 5P50AR070591-05
- **Recipient organization:** NEW YORK UNIVERSITY SCHOOL OF MEDICINE
- **Principal Investigator:** Peter Izmirly
- **Activity code:** P50 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $191,040
- **Award type:** 5
- **Project period:** 2017-09-22 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10249212

## Citation

> US National Institutes of Health, RePORTER application 10249212, Core 2 - Clinical Core (5P50AR070591-05). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10249212. Licensed CC0.

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