Abstract
Aiming to advance precision medicine in oncology and improve patient care, the American Association for Cancer Research has launched an international initiative known as AACR Project Genomics, Evidence, Neoplasia, Information, Exchange (GENIE). The venture will pool existing and future next-generation clinical sequencing data with longitudinal clinical outcomes and related pathology reports from several institutions in the United States, Canada, and Europe, to find new mutations, assess potential biomarkers, and identify patient populations that might benefit from existing treatments.
Aiming to serve as a catalyst for the advancement and adoption of precision medicine in oncology, the American Association for Cancer Research (AACR) has launched an international initiative known as AACR Project Genomics, Evidence, Neoplasia, Information, Exchange (GENIE). The venture will pool existing and future next-generation clinical sequencing data with longitudinal clinical outcomes and related pathology reports from several institutions in the United States, Canada, and Europe.
“The need for such a project is great,” said Charles L. Sawyers, MD, a physician-scientist at Memorial Sloan Kettering Cancer Center (MSKCC) in New York, NY, and one of several researchers who unveiled the project on November 6 at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston, MA. Sawyers, who conceived the effort and chairs its steering committee, explained that the explosion of sequencing projects “has created a treasure trove of data,” but that the data often remain at the institution that conducted the sequencing, limiting their potential value and statistical significance.
“These data are typically insufficient in number or lack the necessary clinical outcomes data to be clinically meaningful,” said Sawyers. “Thus, to effectively benefit patients, the genomic and clinical outcomes data from as many institutions as is practical should be combined through a data-sharing initiative.”
Launched and funded for 2 years with $2 million from the AACR, the Project GENIE registry already contains more than 17,000 genomic records, many related to late-stage and rare cancers. Size is just one of the strengths of Project GENIE, and one trait that similar efforts lack. It will also include both retrospective and prospective data contributed by its seven founding members:
The Center for Personalized Cancer Treatment, Utrecht, the Netherlands
Dana-Farber Cancer Institute (DFCI), Boston, MA
Institut Gustave Roussy, Villejuif, France
Johns Hopkins University's Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD
Memorial Sloan Kettering Cancer Center, New York, NY
Princess Margaret Cancer Centre, Toronto, Canada
Vanderbilt-Ingram Cancer Center, Nashville, TN.
As these institutions treat new patients, additional data—stripped of all identifying information to maintain patients' privacy—will be added to the registry, which includes only clinical-grade sequencing data that have been used in clinical decision making. All of the sequencing data are Clinical Laboratory Improvement Amendments– and International Organization for Standardization–certified.
To overcome some of the challenges of merging data from different institutions, project partner Sage Bionetworks of Seattle, WA, will ensure the data's provenance, perform quality assurance, and make other needed changes to harmonize the data; none of the participants will need to change their platforms or protocols for data collection, which would have been a deterrent to participation. “Cleaned” data will then be transferred to a cloud-based platform where it can be viewed and analyzed through cBioPortal, based at MSKCC, explained Justin Guinney, PhD, director of computational oncology at Sage.
Charles L. Sawyers, MD, explains the genesis of the GENIE Project at the press conference where the data-sharing project was announced.
Charles L. Sawyers, MD, explains the genesis of the GENIE Project at the press conference where the data-sharing project was announced.
Sawyers and Barrett Rollins, MD, PhD, a member of the AACR Project GENIE steering committee and chief scientific officer at DFCI, said that the searchable database may aid researchers and patients in multiple ways—for example, by developing new hypotheses for translational and clinical studies; validating biomarkers of treatment response and prognosis; identifying new patient populations that might benefit from existing treatments; and discovering novel drug targets.
Before the first data are made public next November, researchers from the seven member institutions will pose a significant clinical question to validate and demonstrate the benefits of AACR Project GENIE. After that, other scientists can propose additional queries. More data will be available over time.
“We believe it's an extremely valuable project,” said Rollins. “We want to share it with cancer researchers around the world … It's a database like no other.” –Suzanne Rose
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