On 16 May 2018, the American Association for Cancer Research (AACR) announced that the number of institutions participating in the AACR initiative known as AACR Project Genomics Evidence Neoplasia Information Exchange (GENIE) has increased by eleven. With this, there are now 19 institutions contributing clinical-grade genomic and clinical outcomes data to the registry, and more are anticipated to be added in the near future.
Among eleven new participants of the AACR Project GENIE consortium and their related cancer centres, there are two institutions from Europe: Cancer Research UK Cambridge Centre, University of Cambridge, England; and Vall d’Hebron Institute of Oncology, Barcelona, Spain. With this, there are now 4 European institutions contributing to the registry. Two founding consortium participants are Gustave Roussy Cancer Campus, Paris-Villejuif, France and The Netherlands Cancer Institute, Amsterdam, on behalf of the Center for Personalized Cancer Treatment, Utrecht, The Netherlands.
In just two years, the founding institutions of the project have been able to accumulate and make public more than 39,000 de-identified genomic records. Now when consortium has more than doubled in size, it is anticipated to see a substantial acceleration in the pace at which the registry will grow.
The first public release of cancer genomic data aggregated through AACR Project GENIE occurred on 5 January 2017. It included nearly 19,000 de-identified genomic records. Two further public releases of 12,869 and 7,600 de-identified genomic records on 22 November 2017 and 9 January 2018, respectively, increased the registry to 39,600. Data from new participating institutions are expected in the January 2019 public release.
Project GENIE's approach to data harmonization is such that each participating organisation can continue to operate how it best sees fit while simultaneously contributing its data to the project. In this manner, future participants can and will be easily added once the pilot phase of the project is concluded, and financial milestones are met.
Requirements of participating institutions are to provide 500 genomic records to start; 500 each subsequent year of participation. Data must be CLIA- or ISO-certified. Limited data sets as defined by 45 C.F.R. § 164.514(e) will be provided, if de-identified datasets are provided, the process must adhere to the project’s established protocol. Participating institutions should agree to provide the requested clinical data elements, maintain IRB approval, meet data standards and deadlines, participate in meetings, participate on committees and subcommittees, execute the Master Participation Agreement and agree to all exhibits, including the Data User Agreement.
Informatics partners in the programme are Sage Bionetworks, Seattle, Washington, and cBioPortal, New York, US. Criteria for informatics strategic partners are significant prior experience in similar projects, secure, HIPAA-compliant infrastructure, established and accepted platforms, as well as significant bioinformatics expertise.