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 5,000 diverse participants for the Pathfinder 2 study, in which participants provide a blood sample that is screened for over 50 types of cancer. We give participants the results and offer diagnostic workup to confirm them.
• 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.

Our currently enrolling trials and partners include:

GRAIL, LLC

• Pathfinder 2: This is a follow-up investigation into GRAIL's Galleri multi-cancer early detection test. The goal is to evaluate the safety and performance in a diverse screening population. PI: Dr. Nima Nabavizadeh, M.D.

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. 

DELFI Diagnostics, Inc.

• Delfi-L101: The goal is to obtain clinically categorized whole blood specimens from participants with a new or suspected cancer diagnosis. Specimens will be used to train and test classifiers for lung cancer detection using DELFI assay and other biomarker and clinical features. PI: Dr. Nima Nabavizadeh, M.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.

Guardant Health, Inc.

• SHIELD: The goal is to evaluate the sensitivity and specificity of a blood-based Guardant LUNAR-2 test to detect high-frequency cancer in screen-relevant populations. PI: Dr. Joshua M. Walker, M.D., Ph.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.

Trials and partners with completed enrollment:

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