The VA recently launched the Precision Oncology Program (POP), a clinical program that provides a turnkey operation for targeted sequencing of tumor samples and return of annotated results to the patient record. The Program recommends available clinical trials and consultative advice to clinicians and patients. We describe here the accompanying Research Program (Re-POP) that leverages the artifacts of the POP.
Lung cancer patients whose tumors are sequenced as part of the clinical POP will be given the opportunity to participate in the research Program. The goals of the Re-POP include: 1) creation of a network of VA sites to participate as a consortium in clinical trials; 2) provision of a research data repository containing information regarding tumor features including mutational status, patient demographics, and cancer treatments and outcomes; and 3) re-use of residual patient tumor tissue for expanded analysis.
Through collaborative efforts with research groups Re-POP will open large trials on a national level throughout the VA. Use of a centralized IRB and coordinating center (at Massachusetts Veterans Epidemiology Research and Information Center) will facilitate opening studies at any VA site that wishes to participate. The VA Cooperative Studies Program will support these activities. Preliminary data suggest that the Program can make available protocols offering either experimental or off-label therapies for approximately half of all nonsmall cell lung cancer patients.
The Re-POP data repository will reside at the NCI Genomic Data Commons and is available to both academic and industry researchers. Predictive analytics of these data support learning healthcare system activities (predicting individual patient outcomes) and the production of population-level generalizable knowledge.
Residual tissue and clinical data from Re-POP will be made available to researchers to identify new biomarkers that will enhance understanding of response to therapies as well as identify new therapeutic targets. An NCI-VA-DoD collaboration to study the value of proteomics in predicting response to targeted therapies in lung cancer was recently announced as part of the White House’s cancer moonshot initiative.