Clinical trials are a vital tool for testing new ways to detect cancer early. However, trials for early cancer detection have special requirements. They need cohorts that are large and diverse. Researchers seeking to validate early detection methods often need partners to help them implement these trials. That’s where we come in.

The clinical trials team at CEDAR offers expertise in recruiting and managing cohorts of unique scale and diversity. Working closely with Knight Community Outreach and Education, OHSU CORE and other partners, we achieved these milestones:

• Recruited more than 6,000 study participants in the Pathfinder 2 Study, encompassing a diverse scope among numerous communities in the State of Oregon. Participants in this study provide a small blood sample that is screened for more than 50 types of cancer signals, participants are given results and are offered diagnostic workup to confirm the accuracy of the blood test.
• Partnered with health care systems in Portland, Vancouver, Salem, Coos Bay, Roseburg and the Columbia Gorge.
• Conducted hundreds of research visits in a language other than English.

Currently enrolling trials and partners include:

Freenome Holdings, Inc.

• The PROACT LUNG Study: The goal is clinical validation of the Freenome multiomics blood test for lung cancer (FMBT-Lung) including sensitivity and specificity in detecting lung cancer among subjects with positive and negative lung cancer outcomes. PI: Dr. Joshua M. Walker, M.D., Ph.D. 

Adela, Inc.

• CAMPERR: The goal is to train and validate the methylome profiling platform of Adela’s cfMeDIP-seq test to detect and differentiate multiple cancer types. PI: Dr. Nima Nabavizadeh, M.D.

University of Washington

• PATROL: The goal is to determine the positive predictive value of predefined age-directed PSA thresholds for biopsy to detect prostate cancer in people with prostates who are germline carriers of known or suspected pathogenic variants in genes associated with prostate cancer risk. PI: Dr. Alexandra Sokolova, M.D.

GRAIL, LLC 

• REACH: The purpose of this study is to assess the performance of a multi-cancer early detection (MCED) test designed to detect many types of cancer and to assess how doctors use the results of the test in clinical practice. PI: Dr. Nima Nabavizadeh, M.D.

Pending studies:

• Guardant Health, Inc. - SHIELD

Trials and partners with completed enrollment:

• GRAIL, LLC – Pathfinder 1
• GRAIL, LLC – Pathfinder 2 
• GRAIL, LLC – Expanded Access Program
• DELFI Diagnostics, Inc. - Delfi-L201: CASCADE-LUNG
• DELFI Diagnostics, Inc. - Delfi-L101
• Exact Sciences Corporation – Ascend II
• Freenome Holdings, Inc. – Preempt
• Freenome Holdings, Inc. – Project Danube
• Freenome Holdings, Inc. – The Sanderson Study