As a program within the Biostatistics Program in the Public Health Sciences Division of Fred Hutchinson 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.
Our Mission:
COMPASS promotes scientific excellence in research aimed at eliminating cancer and other diseases of public health importance by providing state-of-the-art study coordination, communication and statistical analysis services to scientific investigators.
COMPASS fulfills its mission by:
- pursuing scientific excellence and innovation in the conduct of research studies
- attracting and retaining the highest quality faculty, management, and staff
- maintaining a dynamic organizational structure capable of sustaining multiple studies
- promoting mutual respect, teamwork, and open sharing of ideas
- providing full-spectrum operational support for research
- fostering innovative science and accelerated outcomes by bringing together diverse teams across multiple disciplines
Current COMPASS studies
PI: Ziding Feng, PhD
Contact:
Jackie Dahlgren
edi-dmcc@fredhutch.org
The Early Detection Initiative (EDI) for Pancreatic Cancer is a multi-center, prospective study to evaluate algorithm-based screening in patients with glycemically defined new onset diabetes (G-NOD) to assess the risk for and early detection of pancreatic ductal adenocarcinoma (PDAC). The study focus is on validating the Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score for enrichment of risk of PDAC and to quantify clinically meaningful lead time for earlier detection of PDAC.
COMPASS serves as the data management and coordinating center for EDI. The Pancreatic Cancer Action Network (PanCAN) is the sponsor of the study.
PIs: Yingye Zheng, PhD, Ziding Feng, PhD, Ruth Etzioni, PhD
Contact:
Jackie Dahlgren
edrndmcc@fredhutch.org
The Early Detection Research Network (EDRN) is a national network founded in 1999 for the development, evaluation, and validation of biomarkers for early detection and risk assessment for cancer. Biomarkers are cellular, biochemical, molecular or genetic alterations by which a normal or abnormal biologic process can be recognized or monitored. Biomarkers are measurable in biological media, such as fluids, tissues or cells.
In addition to the National Cancer Institute (NCI), which funds the EDRN, there are three components to the network: Biomarker Characterization Centers, Clinical Validation Centers and a Data Management and Coordinating Center (DMCC). Under the direction of Principal Investigator Dr. Yingye Zheng, the DMCC provides logistical, informatics and statistical services to the EDRN.
The EDRN DMCC, funded in 2000, provides logistical support and coordination for 66 EDRN PIs; coordinates meetings, conference calls and workshops; develops and manages the EDRN secure website; develops and maintains, in collaboration with the NASA Jet Propulsion Laboratory, the EDRN public portal website; participates in the review of validation studies and associate member applications; manages and coordinates EDRN validation studies and Clinical Utility Trials; develops and maintains the Validation Study Information Management System (VSIMS) or COMPASS Data Management System (CDMS) for data collection and management; specimen tracking and study monitoring; and conducts statistical methodology research for EDRN.
The DMCC, operated by COMPASS, Fred Hutch (Drs. Yingye Zheng, Ziding Feng, Ruth Etzioni, Chad He, Ying Huang, Yingqi Zhao, Tracey Marsh), the University of Washington (Dr. Eardi Lila) and statisticians at Dana Farber/Harvard (Dr. Nabihah Tayob), provides coordination and data management for the EDRN under the direction of the steering committee and develops statistical and analytical methods in response to the scientific needs of the network. Specific tasks performed by at the DMCC include:
- Network coordination: produce operating policy and procedure manuals; assist in the development and implementation of collaborative study research protocols; develop and maintain a network secure website and listserv; provide logistical and administrative support for meetings; and provide statistical support for collaborative studies within the network and statistical consultation to center-specific studies.
- Data management: provide data management support for collaborative studies in the network, including developing data collection protocols; monitoring adherence, developing and maintaining databases; and providing reports or study data as needed.
- Theoretical and applied research: develop statistical and analytical methods for biomarker evaluation and interpretation, specifically focusing on the development and evaluation of flexible descriptive statistical methods 1) to assess the reliability and reproducibility of biomarkers and to identify factors that contribute to reducing reliability, 2) to assess the accuracy of a biomarker for cancer detection or cancer risk assessment, and factors influencing its diagnostic potential, both when a gold standard exists, and when one does not, 3) to identify cancer heterogeneity for specific biomarkers, and 4) to identify biomarkers from microarray expression data.
PI: Yingye Zheng, PhD
Contact:
Jackie Dahlgren
lbc-dmcu@fredhutch.org
The Liquid Biopsy Consortium (LBC) is an academic/industrial partnership program designed to advance and validate liquid biopsy technologies specifically targeted for early stage cancer detection. The goal is to test 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 LBC is also working on methods to distinguish cancer from benign disease, or aggressive from indolent cancers. Projects from funded sites 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. The sponsor is the Division of Cancer Prevention at the National Cancer Institute.
PI: Ziding Feng, PhD
Contact:
Jackie Dahlgren
nod-dmcc@fredhutch.org
The New-Onset Diabetes (NOD) cohort is jointly funded by NCI and NIDDK and is part of the Consortium for the study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC). The CPDPC sub-contracted NOD coordination to the Early Detection Research Network - Data Management and Coordinating Center. The goals of NOD are to prospectively assemble a cohort of subjects >50 and ≤85 years of age with New-Onset Diabetes (NOD), called the NOD Cohort, in order to:
- Estimate the probability of pancreatic ductal adenocarcinoma (PDAC) in the NOD Cohort
- Establish a biobank of clinically annotated biospecimens including a reference set of biospecimens from pre-symptomatic PDAC and control new-onset type 2 diabetes mellitus (DM) subjects
- Facilitate validation of emerging tests for identifying NOD subjects at high risk for having PDAC using the reference set
- Provide a platform for development of an interventional protocol for early detection of sporadic PDAC NOD subjects
NOD recruitment ended in May of 2022 and is on-track to end in mid-2025 with specimens collected from NOD being available as a specimen reference set through the Early Detection Research Network.
For information on the Prostate Active Surveillance Study sponsored by the Canary Foundation visit https://canarypass.org/
PI: Yingye Zheng, PhD
Contact:
Stephanie Page-Lester
206.667.4988
PI: Ziding Feng, PhD
Contact:
Stephanie Page-Lester
tlc-dmcc@fredhutch.org
The Translational Liver Cancer (TLC) Consortium is an NCI-funded consortium founded to advance translational research focused on early detection of liver cancer. Under the direction of the Consortium Steering Committee, the Data Management and Coordinating Center (DMCC) will:
- Perform network coordination and promote collaborations among scientific investigators by providing support for Consortium meetings, developing and maintaining Consortium secure websites and listservs, and producing and maintaining all Consortium documents
- Support Consortium collaborative studies by working with Consortium investigators on study design, protocol development, data forms, and study manuals; coordinating and monitoring studies; tracking specimen sharing, blinding, and randomization; and performing QA/QC and study evaluation
- Develop and maintain a Consortium integrated information management system that provides online, end-to- end data management solutions, including study communications, regulatory compliance, remote patient registration, clinical data capture, biospecimen sample management, imaging data repository, document management, and informatic tools
- Use the phased biomarker development guidelines and PRoBE study design standards to help the Consortium develop a roadmap and strategies and ensure rigor and efficiency of the Consortium collaborative phase-2 and phase-3 studies using existing and newly collected specimens from heterogeneous cohorts.
Contact COMPASS
Director: Yingye Zheng, PhD
Co-Director: Jackie Dahlgren