# Clinical Core

> **NIH NIH U54** · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · 2022 · $397,182

## Abstract

CLINICAL CORE: ABSTRACT
The central mission of the Clinical Core (CC) is to oversee all aspects of clinical study development, patient
recruitment and specimen collection for analysis in the Center’s scientific projects. The CC is led by Drs. Paul
Bunn, Philip Mack, and Jorge Gomez. Together with co-investigators Dr. Brody (Director of Mount Sinai Cancer
Biorepository) and Drs. Henschke and Yankelevitz (Directors of the Mount Sinai Lung Cancer Screening
Network), the CC brings to bear a wealth of experience in clinical trials development, translational medicine and
biorepository management. As described in Aim 1, the CC will be responsible for development, compliance,
IRB-approval, implementation and monitoring of the clinical study that serves as the basis for this U54 Center.
A foremost responsibility of the CC will be to rigorously maintain all regulatory, safety, privacy, confidentiality and
compliance elements necessary for clinical study enrollment. Leveraging the experience and infrastructure of
the Mount Sinai Tisch Cancer Institute Clinical Trials Office, the CC will oversee all study enrollment, following
all HIPAA and regulatory compliance elements. While developed and managed by the CC, the study will be
implemented in close partnership with the Data Science Core, and Project Investigators, under the guidance
of the Center leadership and Steering Committee. In Aim 2, the CC will Identify and enroll lung cancer and
control subjects onto the study, collecting the required longitudinal clinical information and serial blood
specimens. Lung cancer patients will be recruited mostly from Mount Sinai. Some patients of special interest
(younger, minorities) will be recruited through the GO2 Foundation for Lung Cancer network. Non-lung cancer
matched controls will be recruited from the Mount Sinai Lung Cancer Screening Program, and will be composed
of individuals with no evidence of lung cancer and no active cancer within the last 5 years (except skin cancer),
matched by age, gender, ethnicity and tobacco smoking history. As vaccines become available, recruitment will
segue from studying antibody response to natural infection with SARS-CoV-2 to vaccine-induced antibodies
responses. Aim 3 addresses the collection, processing, storage, encoding and delivery of high-quality
specimens to Project Investigators. From all study participants, blood specimens will be collected prospectively
at baseline, and 3, 6, 12 and 24 month following enrollment. The CC will serve as a conduit between the Projects
and the Data Science Core by providing HIPAA-compliant data and samples that have been anonymized to the
project investigators conducting assays. The CC will utilize the existing infrastructure of the Tisch Cancer
Institute’s Biorepository, maintaining its own partitioned, password-protected database and dedicated, well-
monitored freezer space.

## Key facts

- **NIH application ID:** 10688375
- **Project number:** 4U54CA260560-02
- **Recipient organization:** ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
- **Principal Investigator:** PHILIP C MACK
- **Activity code:** U54 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $397,182
- **Award type:** 4N
- **Project period:** 2020-09-30 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10688375

## Citation

> US National Institutes of Health, RePORTER application 10688375, Clinical Core (4U54CA260560-02). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10688375. Licensed CC0.

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