# Clinical Subjects and Biospecimen Core

> **NIH NIH U19** · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · 2020 · $378,112

## Abstract

PROJECT SUMMARY/ABSTRACT
The Clinical Subject and Biospecimen Core will provide a core resource for the recruitment and
characterization of human subjects, the completion of the clinical studies, and the collection and processing of
biospecimens from these subjects. Recruiting human subjects for translational research protocols requires
well-developed systems to ensure successful subject recruitment and the collection of high quality
biospecimens from well-characterized human subjects. Dr. Nirav Bhakta (Core Director), Dr. Prescott Woodruff
(Associate Core Director; also Associate Director of the UCSF Airway Clinical Research Center), along with a
team consisting of a research coordinator, a technician, and a programmer analyst, have considerable
experience in all aspects of these systems. Using the resources of this highly experienced and well-resourced
group, the core will have four aims. Aim 1 is to recruit and enroll asthmatic subjects for the 1-year longitudinal
study with bronchoscopy and sputum induction protocols to support Projects 1 and 2; this includes the
management of IRB-related approvals and other regulatory paperwork for human research. Aim 2 is to collect
high quality biospecimens from this new study using systems and methods which ensure compliance with
federal and local regulations. Aim 3 is to bank and create database entries for biospecimens requested from
three already-completed studies: 1) CLAVIER, a longitudinal bronchoscopy study with subjects randomized to
lebrikizumab or placebo, 2) RITA, an 8-week longitudinal study with subjects randomized to inhaled
corticosteroid (ICS) or no ICS, and 3) baseline bronchoscopy visit in the multi-center NIH/NHLBI-funded
Severe Asthma Research Program (SARP). Aim 4 is to provide specialized processing, secure storage, and
timely distribution of the human biospecimens collected from the clinical studies. In addition to providing very
high quality clinical phenotyping and biological specimens from human subjects, this core will perform
specialized 1) processing of induced sputum samples to achieve multiple Project-specific aims from the same
sample, and 2) processing of epithelial brushings for subsequent culture, cryopreservation, single-cell RNA
sequencing, and bulk cell RNA sequencing. For the bulk cell RNA sequencing of epithelial brushings, the core
will perform RNA extractions and assessments of RNA quantity and quality. Given that human studies are an
integral component of this grant application, this core will be critical for the successful performance of each
Project and for establishing the clinical significance of the scientific studies proposed within them. Drs. Bhakta
and Woodruff, and the Airway Clinical Research Center in which they conduct human studies, have a track
record of success in humans subjects recruitment, characterization, research bronchoscopy and sputum
induction, and in the processing, banking, database recording and distribution of high-quality biospecimens
...

## Key facts

- **NIH application ID:** 9901432
- **Project number:** 5U19AI077439-13
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
- **Principal Investigator:** Nirav Rati Bhakta
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $378,112
- **Award type:** 5
- **Project period:** — → —

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9901432

## Citation

> US National Institutes of Health, RePORTER application 9901432, Clinical Subjects and Biospecimen Core (5U19AI077439-13). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9901432. Licensed CC0.

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