My statistical research focuses on design and evaluation of biomarkers and statistical models for cancer risk prediction, early detection, and prognosis. I have active statistical methodology research projects in cancer biomarkers and risk prediction. I am the Principal Investigator of a project to develop statistical methods for prospective evaluation of biomarkers with censored failure time outcome. My statistical research is motivated by my extensive past and ongoing collaborations in the cancer biomarker field. Since joining Fred Hutch in 2002, I have been collaborating extensively in several studies addressing the role of biological and genetic markers in cancer diagnosis and risk stratification. I have been a co-investigator in the Data Management and Coordinating Center (DMCC) of the Early Detection Research Network (EDRN) since 2003, an MPI since 2021, and the contact PI since 2024, providing day-to-day statistical support including study design and data analysis and management of biomarker validation studies. Currently I am the lead statistician of the EDRN prostate cancer collaborative group. I have been the leading statistician for the Prostate cancer Active Surveillance Study (PASS) since 2014 and I am currently leading a study to evaluate commercially available prostate cancer assays to accelerate novel applications in active surveillance. I am also MPI for the Data Management and Coordinating Unit of the Liquid Biopsy Consortium. In addition, I am a on the statistical coordinating center of Population-Based Research Optimizing Screening through Personalized Regimens (PROSPR) aiming to improve the screening process (recruitment, screening, diagnosis, referral for treatment) for lung, colorectal, and cervical cancer with electronic medical records. In summary, I have a demonstrated record of successful and productive research projects and extensive collaborative experience in cancer biomarker research. Together this experience makes me uniquely prepared to contribute to the proposed research.

Projects

Improve the Design and Analysis of Randomized Screening Trial in a New Era of Cancer Early Detection

Role: MPI

Novel blood tests offer a noninvasive way to detect cancer early. However, despite the simplicity of these tests, follow-up actions from the test results may be costly or harmful. The quick introduction of these tests requires reevaluating how novel early-detection biomarkers are assessed. 

Large screening trials are often needed when evaluating new cancer screening tests, where participants randomly receive new screening tests or usual care. These trials take a long time to assess if the new test lowers the chances of dying from cancer. Researchers have proposed to look at short-term results, but sometimes, big drops in these results may not mean significant reductions in cancer deaths. Better approaches to studying these tests, considering the benefits and potential harms they might cause, are urgently needed.  

This study aims to improve the design and analysis of randomized screening trials so that researchers can more quickly learn if the new tests can reduce the probability of cancer deaths and if they are harmful. Improving how the randomized screening trials are designed and analyzing the study results can speed up the evaluation process of new screening tests. This could lead to faster sharing of effective screening methods to the public and provide balanced information about their benefits and harms for shared and informed decision making. It will ultimately help reduce the disease burden and improve patients' outcomes.

Early Detection Research Network Data Management and Coordinating Center

Role: Contact PI

The mission of the Early Detection Research Network (EDRN) is to discover, develop and validate biomarkers and imaging methods to detect early stage cancers and to assess risk for developing cancer, and to translate these biomarkers and imaging methods into clinical tests. A consortium of more than 300 investigators at academic institutions and in the private sector are working collaboratively to bring biomarkers and imaging methods to clinical use.

The EDRN DMCC, funded in 2000, provides logistical support and coordination for 59 institutions in EDRN; coordinates meetings, conference calls, and workshops; develops and manages the EDRN secure website; collaborates with the Jet Propulsion Laboratories to maintain the EDRN public portal; participates in the review of validation studies and associate member applications; manages and coordinates EDRN validation studies; develops and maintains the Validation Study Information Management System (VSIMS) for data collection and management; specimen tracking and study monitoring; and conducts statistical methodology research for EDRN.

Liquid Biopsy Consortium

Role: MPI

In the era of personalized medicine, it is desirable to have noninvasive or minimally invasive methods to determine and follow longitudinally the molecular composition and characterization of a patient’s tumor, which will help gain a broader understanding of the disease. One such approach is through liquid biopsy that can be used to molecularly characterize the tumor and monitor genetic changes over time using repeat sampling of biofluids. Liquid biopsy generally refers to detecting circulating tumor cells (CTC), circulating tumor DNA (ctDNA), circulating exosomes and other analytes in body fluids, such as serum, plasma, urine, etc.​​​ The NCI’s Division of Cancer Prevention has developed and sponsored an Academic/Industrial Partnership program designed to advance and validate Liquid Biopsy technologies specifically targeted for early stage cancer detection. Liquid biopsy uses body fluids such as blood, urine, saliva, stool, and sputum from patients suspected to have early stage cancer as well as those at high risk of developing cancer. The Liquid Biopsy Consortium is also working on methods to distinguish cancer from benign disease; or aggressive from indolent cancers. Projects focus on the development of new tools/methods/assays and/or validations of existing technologies/methods involving the capture of DNA, RNA, or exosomes in circulating body fluids.​

Canary PASS

Role: Lead Statistician

The Canary Prostate Active Surveillance Study (PASS) is a multi-center research study for people who have chosen active surveillance to manage their prostate cancer. Active surveillance in PASS means closely monitoring men with prostate cancer and offering treatment if test results show the cancer is getting worse.

Prostate cancer is the most common cancer among men. In the U.S. in 2017, there will be approximately 160,000 men diagnosed with prostate cancer, and about 26,500 deaths from prostate cancer. Prostate cancer treatment choices are complicated because the majority of prostate cancers will not be lethal, even if left untreated. Doctors cannot always tell which cancers can remain untreated and which will become more aggressive. As a result, some men may receive treatment unnecessarily and some men may not receive sufficient treatment. This study seeks to discover markers to distinguish aggressive cancers from less aggressive cancers. We aim to develop new tests and better strategies to help men decide if and when their cancers need treatment. Information from PASS may help develop better tests to predict prostate cancer outcomes.

There are 11 clinical sites enrolling patients across the U.S. and Canada in addition to the coordinating center based at the Fred Hutchinson Cancer Research Center, in Seattle.

COMPASS

Role: Director

As a program within the Biostatistics Program in the Public Health Sciences Division of Fred Hutch Cancer Center, COMPASS has been directing multi-center studies in public health research for over 30 years.

COMPASS provides study project management and coordination; logistical support; data management and statistical support; Institutional Review Board (IRB) monitoring and compliance; quality control/quality assurance through data review and site visits; web-based data collection and management systems and specimen tracking systems.

The COMPASS organization was formed in 1983 when we established and began coordinating the Carotene and Retinol Efficacy Trial (CARET), a multi-center lung cancer prevention trial. In early 2024, CARET moved to the Cancer Prevention Program under Dr. Marian Neuhouser.

In 2000, we began to expand and now manage several large-scale research networks and studies, including the Early Detection Research Network (EDRN), Early Detection Initiative (EDI), Liquid Biopsy Consortium (LBC), New-Onset Diabetes (NOD) cohort, Prostate Active Surveillance Study (PASS) and the Translational Liver Cancer (TLC) Consortium, and have been involved in numerous smaller collaborations.