# Core 2: Biostatistical and Clinical Core

> **NIH NIH P50** · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · 2023 · $165,701

## Abstract

Project Summary/Abstract
The Biostatistical and Clinical Core will provide the expertise need to support the research of all three SPORE
Projects and the Developmental Research and Career Enhancement projects. Integration of the biostatistical
and clinical research teams in this Core ensures well-founded experimental designs in the planning phase and
allows for adjustments in planned analyses and experiments. A single shared Core will improve the performance
of SPORE-driven projects and clinical trials and ensure that the work is coordinated and cost-effective. The Core
leaders have considerable combined experience managing challenges arising in the design and conduct of
clinical studies for brain tumors including knowledge of molecular subtypes, neuroimaging endpoints, on-
treatment tumor tissue collection and analysis, and toxicity assessments. The Biostatistics Co-leader is Annette
Molinaro, Ph.D., will work with individual leaders from all three Projects to assess the statistical and database
needs. She will provide advice on the design of experimental and clinical studies, including the clinical trial in
Aim 1 of Project 3; data analysis guidance (either by performing the analyses within the core or advising qualified
personnel within the projects), including the use of appropriate statistical models and appropriate applications of
statistical tests; and the development of novel methods to help interpret results from experiments. Under Dr.
Molinaro’s supervision, the Core built and will continue to expand and maintain the UCSF Brain Tumor Center
Database (BTCDB). The BTCDB will be the primary, centralized repository for annotated research and clinical
data used by all SPORE investigators. This unique and customizable resource will connect clinical information
to imaging, tissue, and genomic parameters generated by the SPORE projects. The Clinical Co-leader, John de
Groot, M.D., will interact with all Project leaders in planning and conducting clinical studies and assessing results
including review of the prognostic value of blood immunomethylomics from the population science studies in
Project 1 and evaluating the effect of novel metabolic imaging studies in patients in Project 2. Importantly, Dr. de
Groot will be instrumental in developing and conducting a planned clinical trial in Project 3. The Core will oversee
all clinical studies, provide clinical research nurses and data coordinators, and assist in the required regulatory
and compliance reporting. Working with Dr. Clarke, the clinical co-PI for Project 3, Dr. de Groot will facilitate
interactions with the Hematology, Blood and Marrow Transplantation, and Cellular Therapy program (HBC) and
Living Therapeutics Initiative Program at UCSF, NCI, and FDA, to efficiently activate and conduct the clinical
trial. The primary objective of this Core is to support the translational research of the Projects that are designed
to identify robust prognostic markers; to develop non-invasive imaging te...

## Key facts

- **NIH application ID:** 10712674
- **Project number:** 2P50CA097257-21
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
- **Principal Investigator:** ANNETTE M MOLINARO
- **Activity code:** P50 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $165,701
- **Award type:** 2
- **Project period:** 2002-09-20 → 2028-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10712674

## Citation

> US National Institutes of Health, RePORTER application 10712674, Core 2: Biostatistical and Clinical Core (2P50CA097257-21). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10712674. Licensed CC0.

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