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Proffered paper session - Translational research

1704 - Plasma cell-free DNA (cfDNA) assays for early multi-cancer detection: the Circulating Cell-Free Genome Atlas (CCGA) study


20 Oct 2018


Proffered paper session - Translational research


Translational Research

Tumour Site


Minetta Liu


Annals of Oncology (2018) 29 (suppl_8): viii14-viii57. 10.1093/annonc/mdy269


M.C. Liu1, E. Klein2, E. Hubbell3, T. Maddala3, A.M. Aravanis3, J.F. Beausang4, D. Filippova4, S. Gross4, A. Jamshidi4, K. Kurtzman4, L. Shen4, N. Zhang4, O. Venn4, J. Yecies4, S. Patel4, D.A. Smith5, T. Yeatman6, M. Seiden7, A. Hartman4, G. Oxnard8

Author affiliations

  • 1 Division Of Medical Oncology, Department Of Oncology, Mayo Clinic Cancer Center, 55905 - Rochester/US
  • 2 Glickman Urological And Kidney Institute, Cleveland Clinic, 44195 - Cleveland/US
  • 3 Clinical Development And Medical Affairs, GRAIL, 94025 - Menlo Park/US
  • 4 Research And Development, GRAIL, Inc., 94025 - Menlo Park/US
  • 5 Research, Compass Oncology, 98684 - Vancouver/US
  • 6 Smc Division Of Surgery, Gibbs Cancer Center and Research Institute, 29303 - Spartanburg/US
  • 7 Research And Development, US Oncology Research, 77380 - The Woodlands/US
  • 8 Medicine, Dana-Farber Cancer Institute, 2215 - Boston/US


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Abstract 1704


A noninvasive cfDNA blood test detecting multiple high-mortality cancers at early stages when treatment is more likely effective could decrease cancer mortality. CCGA (NCT02889978) is a prospective multi-center observational study to develop a plasma cfDNA-based multi-cancer detection assay.


Prospectively collected clinically evaluable samples (N = 2402) from non-cancer controls (C) and participants with newly diagnosed untreated cancer (pts; 20 tumor types, all stages) were divided into training (n = 1458; 580 C, 878 pts) and test (n = 944; 368 C, 576 pts) sets and analyzed as a preplanned substudy. Prototype sequencing assays included paired cfDNA/white blood cell (WBC, 60000X) targeted sequencing, paired cfDNA/WBC whole genome sequencing (30X), cfDNA whole genome bisulfite sequencing (WGBS, 30X). Sensitivity was estimated at 98% specificity. Cancers with >5 pts in training and test are reported.


Overall, pts (all stages) and C had similar age, smoking status, and gender. WGBS returned the highest sensitivity and is included here; results were consistent across the targeted, WGS, and WGBS assays, and will be reported in full. WBC signal was used to correct for clonal hematopoiesis. Stage I-IV cancer detection was consistent in training and test sets. In training, cancer-specific sensitivities (high-signal cancers) ranged from 54-92% and will be reported in detail. In individual cancers in the test set, numbers and sensitivity (95% CI) were: 22 hormone receptor negative breast (36%, 17-59), 45 colorectal (60%, 44-74), 7 esophageal (43%, 10-82), 12 head & neck (50%, 21-79), 15 hepatobiliary (73%, 45-92), 47 lung (70%, 55-83), 22 lymphoma (64%, 41-83), 7 ovarian (71%, 29-96) and 23 pancreatic (74%, 52-90). Results were also consistent between training and test sets in stage I-III and stage IV cancers.


A cfDNA-based blood test detected multiple cancers at various stages consistently in training and test sets. This approach is promising as a multi-cancer early detection test, including for high mortality unscreened cancers where stage shift can impact mortality. Further assay and clinical development of a multi-cancer cfDNA test in large-scale clinical studies, including CCGA, is ongoing.

Clinical trial identification


Legal entity responsible for the study




Editorial Acknowledgement

Writing support provided by Megan P. Hall, PhD (GRAIL, Inc., Menlo Park, CA).


M.C. Liu: Advisory board member: GRAIL, Inc. E. Klein: Consultant: GRAIL Inc., GenomicHealth, GenomeDx. E. Hubbell: Employee: GRAIL, Inc. with options to hold stock; Stock: ThermoFisher. T. Maddala, A.M. Aravanis, J.F. Beausang, D. Filippova, S. Gross, L. Shen, N. Zhang, O. Venn, J. Yecies, S. Patel, A-R. Hartman: Employee: GRAIL, Inc. with options to hold stock in the company. A. Jamshidi, K. Kurtzman: Employee: GRAIL, Inc. with options to hold stock in the company; Stock: Illumina. M. Seiden: Employee and stocks: McKesson. G.Oxnard: Advisory board member, consultant: Inivata; Honorarium: Guardant Health, Sysmex, BioRad; Consultant: DropWorks, AstraZeneca, GRAIL, Inc. All other authors have declared no conflicts of interest.

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